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BloodComponent

InormationCIRCULAR OF INFORMATION

An extension o blood component labels

2009

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Page 2 Blood Component Inormation 2009

Copyright Australian Red Cross Blood Service 2009

Last updated April 2009

Apart rom any air dealing or the use o private study, research, criticism, or review

as permitted under the Copyright Act, no part o this book may be transmitted or

reproduced in any orm, electronic or mechanical, or by any inormation storage and

retrieval system, without the written permission o the Publishers.

NHMRC/ASBT Clinical Practice Guidelines:

CP79 Appropriate Use o Platelets

CP80 Appropriate Use o Fresh Frozen Plasma and Cryoprecipitate

CP81 Appropriate Use o Red Blood Cells

Copyright Commonwealth o Australia, reproduced by permission.

Published in Australia by:

Australian Red Cross Blood Service (ARCBS)

464 St Kilda Road

Melbourne VIC 3004 Australia

www.transusion.com.au

ISBN 978-0-9775199-6-5

Australian governments ully und Red Cross or the provision o blood

products and services to the Australian community.

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Page 3Blood Component Inormation 2009

Table o ContentsIntroduction 4

Blood donor selection and collection o blood 5

Testing o donor blood 5Processing blood into components 6

Blood component therapy 6

Blood component labelling 7

Storage, transport and handling 8

Administration methods 9-10

Adverse reactions 11

Additives and anticoagulants 12-13

WHOLE BLOOD Fresh Unrerigerated Leucocyte Depleted 14

RED CELLS Leucocyte Depleted 15RED CELLS Paediatric Leucocyte Depleted 16

RED CELLS Washed Leucocyte Depleted 17

PLATELETS Apheresis Leucocyte Depleted 18-19

PLATELETS Paediatric Apheresis Leucocyte Depleted 20-21

PLATELETS Pooled Leucocyte Depleted 22

FRESH FROZEN PLASMA 23

FRESH FROZEN PLASMA Paediatric 24

CRYO-DEPLETED PLASMA 25

CRYO-DEPLETED PLASMA Apheresis 26

CRYOPRECIPITATE 27

CRYOPRECIPITATE Apheresis 28

AppendicesAppendix I: NHMRC/ASBT Clinical Practice Guidelines

Appropriate use o red cells, platelets, FFP and cryoprecipitate 29-34

Appendix II: Adverse reactions 35-41

Appendix III: Clinical indications or modifed blood components 42-44

Appendix IV: Explanation o blood component label modier text 45-46

Appendix V: Residual risk estimates or transusion-transmitted inections 47-48

Reerences 49-50

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IntroductionThe purpose o this Blood Component Information(Circular o Inormation) is to describe the blood

components produced by ARCBS, including a description o the blood collection process, method o

manuacture, critical manuacturing steps, clinical indications or use and administration methods.The Blood Component Informationis considered an extension o blood and component labels as the

space on these labels is very limited. Blood components are biological products and blood cells are living

human tissue intended or use in the treatment o patients. Proessional judgment based on clinical

evaluation determines the selection o components, the dosage, the rate o administration and decisions

in situations not covered in this general statement.

The ARCBS vision o sharing lies best git is achieved through partnership with the Australian

community to improve health outcomes, by providing sufcient, quality blood products, tissues and

expert services. ARCBS complies with the regulatory ramework o: the Therapeutic Goods Act, 1989;

Therapeutic Goods Order Standards for Blood Components (No 66); Therapeutic Goods Order Amendment

to Therapeutic Goods Order No 66 - Standards for Blood Components; the Australian Code o Good

Manuacturing Practice Human Blood and Tissues; and the Council o Europe Guide to the Preparation,

Use and Quality Assurance of Blood Components.

IMPORTANT INFORMATIONCareul donor selection and available laboratory tests do NOT eliminate all potential hazards o blood

transusion. The risk o transmitting inectious agents is present, including bacteria, parasites,

viruses, and the agent o variant Creutzeldt-Jakob disease. In addition, blood components may contain

immunising substances other than those indicated on the label. For example, a unit o platelets also

contains residual red blood cells and white blood cells. Serious transusion reactions are rare but may be

lie-threatening. Thereore, this Blood Component Informationas a whole or in part cannot be consideredor interpreted as an expressed or implied warranty o the saety or ftness o the described blood or blood

components when used or their intended purpose.

Attention to the specifc indications or blood components is needed to avoid inappropriate transusion.

Correctly identiying the patient, both during collection o the pre-transusion sample and beore starting

the transusion, is vital in avoiding wrong blood episodes. ABO-incompatible transusions are usually due

to identifcation errors.

Alternatives to homologous blood transusion, including haematinic therapy and autologous transusion

techniques, such as intra-operative cell salvage and pre-operative normovolaemic haemodilution, should

be considered when appropriate, to reduce the potential risks o disease transmission and immune

reactions rom homologous transusions. It should be noted, however, that autologous blood does not

remove all the risks o transusion, particularly the risks o transusion o the wrong blood and bacterial

contamination. The risk/beneft profle o not transusing any product should also be considered.

This Blood Component Informationis supplied to conorm to the regulations o the Therapeutic Goods

Administration (TGA).

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Blood donor selection and collection o bloodIn Australia, blood and its components are collected at fxed and mobile collection centres in accordance

with recommendations rom the World Health Organization (WHO), International Society o Blood

Transusion (ISBT), and the International Federation o Red Cross and Red Crescent Societies, romvolunteer, non-remunerated low-risk donors who have:

satisfactorilycompletedacondentialinterviewanddonordeclarationabouthigh-riskbehaviour,

practices, and circumstances that should cause them to rerain rom donating;

satisfactorilycompletedahealthassessmentthatincludesaquestionnaireonpastandpresent

medical conditions;

satisedminimumphysiologicalcriteria;and

beeninstructedtocontactthebloodservice,evenafterdonation,withanyinformationthatmay

be relevant to their health or which may aect the suitability o their donation.

Blood collection is undertaken in a manner to ensure the saety o the donor and sta whilst maintaining

the saety and efcacy o the collected blood.

Testing o donor bloodBlood donations are tested in order to:

1. Allow appropriate selection o blood or transusion; or example, to permit ABO compatibility

between donor and recipient.

2. Minimise or prevent (where possible) adverse consequences o transusion; or example, to prevent

transmission o inections that can cause disease in transusion recipients.

3. Identiy donors whose donations are not suitable or transusion. For example, donors who carry

transusion-transmissible inections must be notifed and counselled.

All tests are perormed in licensed acilities, according to the principles o good laboratory and

manuacturing practice, and ollowing the manuacturers instructions and strict ARCBS guidelines and

standard operating procedures.

In Australia, mandatory tests or all blood donations are or ABO and Rh(D) blood groups, red cell

antibodies, and the ollowing inections: human immunodefciency virus (HIV) 1 and 2, hepatitis B and

C, human T-cell lymphotrophic virus (HTLV) I and II, and syphilis. Test results are checked beore blood

components are released or clinical use or urther manuacture. Only donations that have satisactory

blood group results, are non-reactive or inectious disease screening and meet other defned specifcations

are released. I an inectious disease screening test is confrmed reactive, the donation is destroyed.

In order to minimise the risk o bacterial contamination o platelets, ARCBS perorms screening by culture

or bacterial contamination on all platelet components.

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Processing blood into componentsBlood component therapy allows tailored treatment to give the patient what is required to correct

a clinical problem. Components are prepared by various methods o physical separation, such as

centriugation. Component therapy makes good use o donated whole blood and other resources. The useo centralised processing acilities, harmonisation o procedures based on a pharmaceutical production

model, and good manuacturing and laboratory practice (GMP/GLP) allows production o a high quality,

sae, consistent product in a controlled and cost-eective manner.

Blood component therapyThe general principles o blood component therapy include:

clinicaldecisionsbasedonacorrectandspecicclinicalandlaboratorydiagnosiswherever

possible; where

transfusiontherapycanprovideshortorlongtermsupport;to

effectivelyandefcientlyprovideorreplacemissingormalfunctioningelementsofthebloodor

immune system; while

bearinginmindrisksandbenetstothepatient;and

consideringavailability,costsandtheimportanceofmakinggooduseofavaluableandlimited

community resource.

For these reasons, whole blood is rarely used or transusion today and most therapy involves the

transusion or administration o specifc blood components.

As with other medicinal therapies, each blood component has specifc clinical indications, known benefts,

and potential adverse reactions. The need or a blood component should take into account the patientsunique circumstances, and the dose should be tailored to the individual clinical situation as appropriate.

The National Health and Medical Research Council (NHMRC) and the Australian Society o Blood

Transusion (ASBT) have published clinical practice guidelines or the use o blood components1. These

are included in Appendix I.

Hospital transusion committees should play an important role in monitoring adherence to national

guidelines, developing local institutional clinical transusion practice policies and procedures, and

supervising educational, training and audit activities and the reporting o adverse reactions. The

Australian and New Zealand Society of Blood Transfusion(ANZSBT) Guidelines or Pretransusion

Laboratory Practice provides guidance with respect to the establishment and responsibilities o hospital

transusion committees2.

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Blood component labellingLabels contain the ollowing inormation:

Propername(e.g.WholeBloodorcomponent),includinganyqualicationsormodications;

Temperaturerangeatwhichthecomponentistobestored; Anticoagulantand/oradditiveusedinthepreparationofthecomponents,whenappropriate,and

the volume;

Contentsorvolume(standardcontent,accordingtothisBlood Component Information, is assumed

unless otherwise indicated on the label);

AnidentierindicatingthatthecollectionandprocessingwasperformedbyARCBS(all

communications should be addressed to ARCBS in your capital city);

Expirydate(andtimeifapplicable),whichvarieswiththecomponent,anticoagulant,additive,and

method o preparation (when the exact expiry time is not indicated, the product expires at midnight

on the day of expiry);

Donationorpoolidenticationnumber;

Whenabloodcomponentissplitintotwoormorecomponents,eachsubunitisidentiedwitha

unique split code;

Donorscategory,e.g.volunteer,autologousordirected;

ABObloodgroupandRh(D)status;

Specialhandlinginformation,asrequired;

Donationtestedandnon-reactiveforHIVI&2,hepatitisB&C,HTLV,andsyphilis;

Thefollowingstatements:

PROPERLY IDENTIFY INTENDED RECIPIENT;

DO NOT USE IF CONTENTS SHOW VISIBLE SIGNS OF DETERIORATION;

WARNING: THIS PRODUCT MAY TRANSMIT INFECTIOUS AGENTS;

SEE CIRCULAR OF INFORMATIONFORCAUTIONS&INSTRUCTIONS.

Blood component labels incorporate variable amounts o clinically important inormation, such as red cell

phenotype, CMV antibody status and irradiation status. It is important that components should always

be transused on the basis that they are positive or negative or particular antigens (e.g. Rh(D), Rh(E), or

K) or have been processed in a particular way (e.g. leucocyte depleted, irradiated) ONLY when the labels

confrm the desired characteristics on the component issued or transusion.

A list o blood component label modifer text and their explanations is provided in Appendix IV.

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Handlingofrefrigeratedcomponentsoutsideofrefrigerationshouldbekepttoaminimumtoensure

that maximum temperature requirements are not exceeded.

Redcellcomponentsmustnotexceed30minutesatroomtemperatureateachoccasionin

accordance with the AABB Technical Manual3 as amended rom time to time.

Componentsshouldbemaintainedinacontrolledtemperatureenvironmentuntiladministered.

Componentsshouldbetransfusedassoonaspossibleafterremovalfromtherequiredstorage

conditions.

Componentsmustbehandledandstoredinawaythatminimisesthepossibilityofproduct

tampering.

Component Storage

Temperature

Range

Transport

Temperature

Range

Comments

Red Cells 2-6C 2-10C All blood rerigerators, including

theatre and other holding

rerigerators, must comply with

AS3864 (1997) as amended rom

time to time.

Whole Blood FreshUnrerigerated

20-24C 20-24C

Fresh Frozen Plasma

Cryo-depleted Plasma

Cryoprecipitate

At or below -25C At or below -25C Plasma reezers must comply with

AS3864 (1997) as amended rom

time to time.

Platelets 20-24C 20-24C Must be stored on a platelet agitator.

Storage, transport and handlingRed cells, resh rozen plasma, cryoprecipitate and platelet concentrates should be stored and transported

at temperatures in compliance with the requirements listed in the table below.

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Administration methodsARCBS recommends that transusing acilities promulgate guidelines with the support o their clinical,

scientifc, and other relevant sta. Institutional guidelines may be based on:

National Health and Medical Research Council (NHMRC) Clinical Practice Guidelines for the

Appropriate Use of Red Cells, Platelets, FFP and Cryoprecipitate1;

Australian and New Zealand Society of Blood Transfusion (ANZSBT) and Royal College of Nursing of

of Australia (RCNA) Guidelines for Administration of Blood Components4;

Australian and New Zealand Society of Blood Transfusion (ANZSBT) Guidelines for

Pretransfusion Laboratory Practice2;

Australian and New Zealand Society of Blood Transfusion (ANZSBT) Guidelines for

Blood Grouping and Antibody Screening in the Antenatal and Prenatal Setting5; and/or

Guidelines of The World Health Organization (WHO)6, British Committee for Standards in

Haematology (BCSH)7, or other appropriate organisations.

The ANZSBT Guidelines provide guidance especially in the areas o sample identifcation, compatibility

testing, issue and transusion o blood components, and investigation o transusion reactions. All clinical

sta involved in ordering, preparing, issuing, and transusing blood components must be trained in the

correct procedures, and must be amiliar with the general and institutional requirements or transusion

practice.

Identifcation o patient, samples, and unit(s) or transusion

Toensurecorrectadministrationofbloodcomponents,theintendedrecipientmustbeproperly

identifed at each stage o the process, rom labelling o samples and request orms at the patients

bedside, through to commencement o transusion.

Theappropriatecomponentmustbeselectedaccordingtospecicclinicalindications.Thisdecision

should be documented on the request orm and in the medical record.

Whenaunitisissuedorreceivedfortransfusion,patientandunitdetailsmustbeconrmed

according to approved procedures. This should be perormed by two qualifed sta.

Transfusionsmustbeclearlydocumentedinthepatientsmedicalrecord,including:indicationfor

transusion; type, number and special requirements o units requested; unique donation numbers o

units transused; starting and fnishing times; periodic vital signs; and other relevant details.

Signaturesandidentityofstaffissuing,transporting,andadministeringtransfusionsmustbe

recorded. Recordsshouldberetainedfortherequiredperiod.

Inspection o components

Priortoissueandtransfusion,componentsshouldbeinspectedvisually.Ifthereisanyevidence

o haemolysis, clot ormation, a signifcant colour change in the blood bag as compared with the

tubing segments, tampering or other suggestion that the unit is not suitable or transusion, it must

not be transused and should be returned to the issuing blood bank or ARCBS or urther evaluation.

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Administration procedures

Componentsshouldbemixedthoroughlybyinversionbeforeuseandthentransfusedthroughan

intravenous line approved or blood administration and incorporating a standard (170-200m) flter

to remove clots and aggregates.

Thecontainermustnotbecompromised(e.g.entered,spiked,vented)priortouse. Nomedicationorsolutionsshouldbeaddedtoorinfusedthroughthesametubingwithblood

components except 0.9 percent Sodium Chloride, Injection. ABO-compatible plasma, 4 percent Albumin,

or other suitable plasma expanders may be used only with approval o the patients physician. Electrolyte

solutions containing calcium (such as Haemacel) must neverbe added to or administered through the

same intravenous line as blood components containing citrated anticoagulant.

Plasmathawingdevices,intravenousuidpumpsandbloodwarmersshouldallbeusedaccording

to the manuacturers instructions. Their saety and appropriateness or blood components should

be established prior to use. Equipment should be monitored and undergo regular maintenance.

Bloodcomponentsmaybewarmedduringorjustpriortotransfusion,ifclinicallyindicated.Only

designated blood warming devices should be used and these must be operated strictly according tothe manuacturers instructions.

Thawfrozenbloodcomponentsusinganapprovedmethodsuchasatemperature-controlled

waterbath maintained between 30 and 37C or in an approvedmicrowave device. Care must be

taken to prevent contamination o entry ports. The use o watertight protective plastic over-wraps is

recommended. Do not thaw components in a domestic microwave oven or under hot water directly

rom the tap.

Bloodcomponentshavebeenpreparedbytechniquesthataidinpreservingsterilityuptothetime

o expiration. I the container is opened in a ashion that violates the integrity o the system or any

reason, the component expires our hours ater opening i maintained at room temperature

(20-24C). Transusion o a particular unit should be completed prior to component expiry or withinour hours, whichever is sooner.

Unlessotherwiseindicatedbythepatientsclinicalcondition,thetransfusionshouldproceedno

aster than 5mL/min or the frst 15 minutes. The patient should be closely observed during this

period as lie-threatening reactions may occur ater only a small volume o blood.

Ifatransfusionreactionoccurs,thetransfusionshouldbediscontinuedimmediatelyand

appropriate therapy initiated. Transusion should not resume without thorough clinical review.

Allsignicantadversereactionstotransfusion,includingpossiblebacterialcontaminationof

a blood component or suspected disease transmission, should be immediately reported to the

transusing acilitys laboratory/blood bank and ARCBS.

Inthecaseofatransfusionreaction,theremainderofanyimplicatedbloodcomponentsshouldberetained or urther investigation.

For more inormation on transusion administration, see publications rom the ANZSBT, RCNA,

WHO, and AABB.

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Adverse reactionsAdverse reactions may be broadly classifed as acute or delayed, and immunological or non-

immunological. See Appendix II or the principal adverse reactions to blood components. Further

inormation on aetiology, incidence, diagnosis, management, and prevention o transusion reactionsappears in:

ARCBS website for health professionals, available at www.transusion.com.au.

Transfusion Reactions, 3rd edition. Popovsky M (ed). AABB Press, Bethesda, 2007.

Serious Hazards of Transfusion Annual Report 2007. Available at www.shotuk.org.

AABB Technical Manual, 16th edition. Roback JD (ed). AABB Press, Bethesda, 2008. Chapter 8:

Inectious disease screening, and Chapter 27: Non-inectious complications o blood transusion.

The Clinical Use of Blood in Medicine, Obstetrics, Paediatrics, Surgery and Anaesthesia, Trauma and

Burns. World Health Organization, Blood Transusion Saety, Geneva, 2005.

Australian and New Zealand Society of Blood Transfusion (ANZSBT) and Royal College of Nursing of

Australia (RCNA) Guidelines for Administration of Blood Components, 2004.

Current risk estimates or disease transmission by blood transusion in Australia are published

periodically in Medilink, available at www.transusion.com.au.

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Additives and anticoagulants

Anticoagulants used or whole blood collections

(61-69mL used or the collection o 450mL + 10% o whole blood)

Constituents in 63mL CPD

(Citrate Phosphate Dextrose)

CPDA-1

(Citrate Phosphate

Dextrose Adenine)

Manuacturer TerumoCorporation

Pall Corporation Fresenius MacoPharma

Sodium citrate dihydrate 1660mg 1656mg 1657mg 1660mg

Citric acid monohydrate 210mg 206mg 206mg 210mg

Dextrose monohydrate 1610mg 1610mg 1610mg 2010mg

Sodium phosphate

dihydrate160mg 140mg 158mg 160mg

Adenine 0mg 0mg 0mg 17.3mg

Red cell additive solution

(100mL used with red cells rom 450mL + 10% o whole blood)

Constituents in 100mL SAGM SAGM-2

Manuacturer Fresenius

MacoPharma

Pall Corporation

Terumo Corporation

Dextrose monohydrate 900mg 0mg

Dextrose anhydrous 0mg 818mg

Sodium chloride 877mg - 880mga 877mg

Mannitol 525mg - 530mgb 525mg

Adenine 17mg 30mg

a Fresenius 877mg; MacoPharma 880mg; Pall Corporation 880mg.b Fresenius 525mg; MacoPharma 530mg; Pall Corporation 525mg.

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Apheresis plasma and platelet collection packs

Pack Type Anticoagulant ormulation

Haemonetics Corporation, product 420J

Contains 250mL

Used or plasma apheresis

Sodium citrate 4% solution:

- 40g/L sodium citrate dihydrate

This is mixed ~1:16 with whole blood.

Baxter Healthcare, product AHB 7898

Contains 500mL

Used or platelet apheresis

ACD-A solution:

- 22.0g/L sodium citrate dihydrate

- 8.0g/L citric acid monohydrate

- 24.5g/L glucose


CaridianBCT, product 777967-900

Contains 750mL

Used or platelet apheresis

ACD-A solution:

- 22.0g/L sodium citrate dihydrate

- 7.3g/L citric acid anhydrous

- 24.5g/L dextrose monohydrate


Platelet additive solution

(300mL used in each platelet pool)Constituents in 300mL SSP+

Manuacturer MacoPharma

Sodium chloride 1215mg

Sodium acetate trihydrate 1326mg

Sodium citrate dihydrate 954mg

Sodium dihydrogenophosphate 315mg

Di-sodium hydrogenophosphate 915mg

Potassium chloride 111mg

Magnesium chloride 90mg

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Description A unit o blood collected into an anticoagulant and fltered to remove most leucocytes.

Whole Blood contains the red cells, platelets and plasma component o donor blood.

Only Whole Blood stored or less than 24 hours at 20-24 oC can be considered a

clinical source o viable platelets or therapeutic levels o labile coagulation Factors

V and VIII.

Indications Limited indications: Indicated only or those patients who have a symptomatic defcit

in oxygen-carrying capacity combined with hypovolaemia o sufcient degree to be

associated with shock, particularly in clinical situations where the transusion o

viable platelets and therapeutic levels o labile coagulation Factors V and VIII are

also required. I only a symptomatic defcit in oxygen-carrying capacity is present, the

component o choice is Red Cells.

Contraindications Depending upon the condition o the patient, transusion containing red cells may

not be necessary even with low haemoglobin concentration. Do not use Whole

Blood or other red blood cell components i anaemia can be treated with specifc

medications such as iron, vitamin B12, olic acid or recombinant erythropoietin

and the clinical condition o the patient permits sufcient time or these agents to

promote erythropoiesis. Do not use Whole Blood when blood volumes can be saely

and adequately replaced with other volume expanders such as 0.9% Sodium Chloride

Injection, Hartmanns Solution, or appropriate colloids. Do not use Whole Blood to

correct coagulation defciencies when they can be treated better with appropriate

components and derivatives.

Specifcation Volume 450mL 10%; Haemoglobin > 45g/unit; Haemolysis (at expiry) < 0.8%;

Platelet count > 60 x 109/unit; Leucocyte count < 1 x 106/unit.

Availability Must be requested in advance.

Shel lie, storage 24 hours at 20-24C.

Dosage and

administration

Each unit contains enough haemoglobin to raise the haemoglobin concentration

in an average sized adult by approximately 10g/L. Whenever possible, blood o

identical ABO and Rh(D) group to the recipient should be used. Transuse through

an intravenous line approved or blood administration and incorporating a standard

(170 to 200m) flter. Transusion o each unit should be completed within our hours

o commencement o transusion.

Adverse reactions Reer to Appendix II: Adverse reactions (page 35-41).

Modifcations Phenotyped; CMV-seronegative; Irradiated. Reer to Appendix III: Clinical indications

or modifed blood components (page 42-44).

WHOLE BLOOD Fresh Unrerigerated Leucocyte Depleted

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Description The red cell component obtained by removing most o the plasma ater

centriuging whole blood collected into anticoagulant. The red cells may be

resuspended in other additives to prolong storage and are fltered to remove most

leucocytes.

Indications For treatment o clinically signifcant anaemia with symptomatic defcit o oxygen

carrying capacity, and or replacement o traumatic or surgical blood loss.

Contraindications Depending upon the condition o the patient, transusion containing red cells

may not be necessary even with low haemoglobin concentration. Do not use Red

Cells i anaemia can be treated with specifc medications such as iron, vitamin

B12, olic acid or recombinant erythropoietin and the clinical condition o the

patient permits sufcient time or these agents to promote erythropoiesis.

Specifcation Volume > 200mL; Haemoglobin > 40g/unit; Haematocrit: 0.50-0.70;

Haemolysis (at expiry) < 0.8%; Leucocyte count < 1 x 10 6/unit.

Availability Available in group O, A, B and AB; and Rh(D) positive and negative groups.

Shel lie, storage 42 days at 2-6oC with the appropriate additives.

Dosage and

administration

Each unit contains enough haemoglobin to raise the haemoglobin concentration

in an average sized adult by approximately 10g/L. Whenever possible, blood

o identical ABO and Rh(D) group to the recipient should be used. However,

group O red cells can be used in an emergency when the recipients blood

group is unknown. In this situation, a blood sample should be taken or blood

grouping prior to commencing transusion. Transuse through an intravenous

line approved or blood administration and incorporating a standard (170 to200m) flter. Transusion o each unit should be completed within our hours o

commencing transusion.


Modifcations Phenotyped; CMV-seronegative; Irradiated. Reer to Appendix III: Clinical

indications or modifed blood components (page 42-44).

Comments Time outside required storage conditions prior to commencing transusion should

not exceed 30 minutes3.

RED CELLS Leucocyte Depleted

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Description The red cell component obtained by removing most o the plasma ater

centriuging whole blood collected into anticoagulant. The red cells may be

resuspended in other additives to prolong storage and are fltered to remove

most leucocytes. The unit is then divided into our packs o equal volume or

the purpose o reducing donor exposure or small paediatric transusions and to

minimise product wastage.

Indications For treatment o clinically signifcant anaemia with symptomatic defcit o

oxygen carrying capacity in inants and young children. May also be used or

intrauterine transusion.

Contraindications As or Red Cells Leucocyte Depleted (page 15).

Specifcation Volume 25-100mL; Haematocrit 0.50-0.70;

Haemolysis (at expiry) < 0.8%; Leucocyte count < 1 x 10 6/unit.

Availability Must be requested in advance, unless by local arrangement.

Shel lie, storage 35 days at 2-6oC.

Dosage and

administration

Whenever possible, blood o identical ABO and Rh(D) group to the recipient

should be used. Transuse through an intravenous line approved or blood

administration and incorporating a standard (170 to 200m) flter. Transusion

o each unit should be completed within our hours o commencement.



indications or modifed blood components (page 42-44).Comment Time outside required storage conditions prior to commencing transusion should


RED CELLS Paediatric Leucocyte Depleted

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Description Red Cells Leucocyte Depleted (page 15) are washed with 0.9% sterile isotonic

saline by a manual method to remove the majority o plasma proteins,

antibodies and electrolytes. The washed red cells are then resuspended in

additive solution.

Indications As or Red Cells Leucocyte Depleted (page 15). Indicated or patients who have

IgA defciency with antibodies against IgA. May reduce the incidence o severe

recurrent ebrile, urticarial and possible anaphylactic transusion reactions in

multitransused patients. For urther indications reer to Appendix III: Clinical


Contraindications As or Red Cells Leucocyte Depleted (page 15).

Specifcation Volume > 130mL; Haemoglobin > 37g/unit; Haematocrit 0.50-0.70;

Haemolysis (at expiry) < 0.8%; Leucocyte count < 1 x 10 6/unit;

Last wash supernatant total protein < 0.5g/unit.

Availability Must be requested in advance.

Shel lie, storage 28 days at 2-6oC i resuspended in additive solution.

Dosage and

administration

Whenever possible, blood o identical ABO and Rh(D) group to the recipient

should be used. Transuse through an intravenous line approved or blood

administration and incorporating a standard (170 to 200m) flter. Transusion

o each unit should be completed within our hours rom commencement o

transusion.




Comment As there is some loss o red cells during processing, the increment in

haemoglobin with this component is less than with an unwashed red cell unit.

Time outside required storage conditions prior to commencing transusion should


RED CELLS Washed Leucocyte Depleted

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Description An adult dose o platelets prepared rom anticoagulated blood which is

separated into components by a suitable apheresis machine with retention o the

platelets and a portion o plasma. The remaining elements may be returned to

the donor. Leucocyte depletion is perormed during or soon ater collection.

Indications Platelets are indicated or treatment o patients with bleeding due to severely

decreased platelet production or bleeding due to unctionally abnormal platelets

(e.g. anti-platelet agents). Platelet transusions are not usually eective

or indicated in patients with rapid platelet destruction. They may be used

in treating some bleeding patients with platelet consumption or dilutional

thrombocytopenia. Platelets may be useul i given prophylactically to patients

with rapidly alling or low platelet counts (usually less than 10 x 10 9/L secondary

to cancer or chemotherapy). Platelet transusion may also be useul in selected

cases o post-operative bleeding (e.g. platelet count less than 50 x 10 9/L.)

Contraindications Do not use this component i bleeding is unrelated to decreased numbers

o platelets or abnormally unctioning platelets. Do not use in patients with

destruction o endogenous and exogenous platelets, such as in immune

thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP)

or heparin-induced thrombocytopenia (HIT), unless the patient has a lie-

threatening haemorrhage.

Specifcation Volume 100-400mL; Platelet count > 200 x 109/unit; pH (at expiry) 6.4-7.4;

Leucocyte count < 1.0 x 106/unit.

Availability Available in group O, A and B; and Rh(D) positive and negative groups. Group AB

must be requested in advance.Shel lie, storage 5 days at 20-24oC. Platelets components must be agitated gently and

continuously in a single layer on a platelet agitator.

PLATELETS Apheresis Leucocyte Depleted

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Dosage and

administration

Compatibility testing is not necessary in routine platelet transusion. Platelet

components should be ABO and Rh(D) type compatible with the recipient.

However, ABO-incompatible platelets may be used i ABO-compatible platelets

are not available. In some patients (particularly children), plasma present in

platelet units which are ABO-incompatible with the recipients red cells may

cause a positive direct antiglobulin test and possible low-grade haemolysis

due to isoagglutinins present in the plasma. In situations where group O

platelets are to be transused to a non-group O recipient, use o apheresis

platelets which have been tested and ound to have low levels o anti-A and

anti-B (low anti-A/B) or pooled platelets should be considered. Immunisation

to donor red cell antigens may occur because o the presence o small but

variable numbers o red cells in platelet units. When Rh(D) positive platelets are

transused to an Rh(D) negative emale o child bearing potential, prevention

o Rh(D) immunisation by use o Rh(D) Immunoglobulin should be considered.Usually 250 IU o Rh(D) Immunoglobulin given intramuscularly per therapeutic

platelet dose provides sufcient cover. I intravenous Rh(D) Immunoglobulin

administration is required, WinRho SDFTM should be used. Transuse platelets

through an intravenous line approved or blood administration and incorporating

a clean standard (170 to 200m) flter. Transusion o each unit may proceed

as ast as tolerated but should be completed within our hours o commencing

transusion. The number o platelet units to be administered depends on the

clinical situation o each patient. One unit o Platelets Apheresis Leucocyte

Depleted would be expected to increase the platelet count o a 70kg adult by

20-40 x 109/L. The usual dose in an adult patient is 1 unit. For prophylaxis,

this dose may need to be repeated in 1-3 days because o the short lie spano transused platelets. Both immune and non-immune mechanisms may

contribute to reduced platelet recovery and survival.


Modifcations CMV-seronegative; Irradiated; HLA-compatible; Phenotyped; Crossmatch-

compatible, Low anti-A/B. Reer to Appendix III: Clinical indications or modifed

blood components (page 42-44).

Comments In addition to platelet-specifc HPA (human platelet antigen) system antigens,

platelets carry HLA class I antigens. Residual white blood cells which may be

present in platelet units express both HLA class I and II antigens. Reractoriness

to platelet transusion may occur ollowing HLA, or less commonly HPA,

alloimmunisation. When transused to a patient with an antibody specifc to an

expressed antigen, the survival time o the transused platelets may be markedly

shortened, and the patient may become either temporarily or permanently

reractory to platelet transusion. HLA-compatible, HPA-matched or crossmatch-

compatible platelets may be indicated.

Platelets Apheresis Leucocyte Depleted continued

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Description Platelets prepared rom anticoagulated blood which is separated intocomponents by a suitable apheresis machine with retention o the plateletsand a portion o plasma. The remaining elements may be returned to the donor.Leucocyte depletion is perormed during or soon ater collection. The unit isthen divided into our packs o equal volume or the purpose o reducing donorexposure or small paediatric transusions and to minimise product wastage.

Indications As or Platelets Apheresis Leucocyte Depleted (page 18-19).

Contraindications As or Platelets Apheresis Leucocyte Depleted (page 18-19).

Specifcation Volume 40-60mL; Platelet count > 60 x 109/pack; pH (at expiry) 6.4-7.4;Leucocyte count < 1.0 x 106/pack.

Availability Contact local ARCBS regarding availability.

Shel lie, storage 5 days at 20-24oC. Platelet components must be agitated gently andcontinuously in a single layer on a platelet agitator.

Dosage and

administration

Compatibility testing is not necessary in routine platelet transusion. Plateletcomponents should be ABO and Rh(D) type compatible with the recipient. However,ABO-incompatible platelets may be used i ABO-compatible platelets are notavailable. In some patients (particularly children), plasma present in platelet unitswhich are ABO-incompatible with the recipients red cells may cause a positivedirect antiglobulin test and possible low-grade haemolysis due to isoagglutininspresent in the plasma. In situations where group O platelets are to be transusedto a non-group O recipient, use o apheresis platelets which have been tested andound to have low levels o anti-A and anti-B (low anti-A/B) should be considered.

Immunisation to donor red cell antigens may occur because o the presence osmall but variable numbers o red cells in platelet units. When Rh(D) positiveplatelets are transused to an Rh(D) negative emale o child bearing potential,prevention o Rh(D) immunisation by use o Rh(D) Immunoglobulin should beconsidered. Usually 250 IU o Rh(D) Immunoglobulin given intramuscularlyper therapeutic platelet dose provides sufcient cover. I intravenous Rh(D)Immunoglobulin administration is required, WinRho SDFTM should be used.Transuse platelets through an intravenous line approved or blood administrationand incorporating a clean standard (170 to 200m) flter. Transusion o each unitmay proceed as ast as tolerated but should be completed within our hours ocommencing transusion. The number o platelet units to be administered depends

on the clinical situation o each patient. One unit o Platelets Paediatric ApheresisLeucocyte Depleted would be expected to increase the platelet count o an 18kgchild by 20 x 109/L. For prophylaxis, doses may need to be repeated in 1-3 daysbecause o the short lie span o transused platelets. Both immune and non-immune mechanisms may contribute to reduced platelet recovery and survival.


PLATELETS Paediatric Apheresis Leucocyte Depleted

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Modifcations CMV-seronegative; Irradiated; HLA-compatible; Phenotyped; Crossmatch-compatible, Low anti-A/B. Reer to Appendix III: Clinical indications or modifedblood components (page 42-44).

Comment As or Platelets Apheresis Leucocyte Depleted (page 18-19).

PLATELETS Paediatric Apheresis Leucocyte Depleted continued

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Description An adult dose o platelets obtained rom a pool o buy coats rom ABO identicaldonors and resuspended in a nutrient additive solution. The platelets are fltered toremove most leucocytes.

Indications As or Platelets Apheresis Leucocyte Depleted (page 18-19).

Contraindications As or Platelets Apheresis Leucocyte Depleted (page 18-19).

Specifcation Volume > 160mL; Platelet count > 240 x 109/pool; pH (at expiry) 6.4-7.4;

Leucocyte count < 0.8 x 106/pool.

Availability Available in groups O, A and B; and Rh(D) positive and negative groups.

Shel lie, storage 5 days at 20-24oC. Platelet components must be agitated gently and

continuously in a single layer on a platelet agitator.

Dosage andadministration Compatibility testing is not necessary in routine platelet transusion. Plateletcomponents should preerably be ABO and Rh(D) type compatible with therecipient. However, ABO-incompatible platelets may be used i ABO-compatibleplatelets are not available. In some patients (particularly children), plasma presentin platelet units which are ABO-incompatible with the recipients red cells maycause a positive direct antiglobulin test and possible low-grade haemolysis dueto isoagglutinins present in the plasma. However, resuspension o the plateletpools in platelet additive solution rather than plasma reduces the risk associatedwith transusion o large volumes o ABO-incompatible plasma and the incidenceo adverse reactions to plasma proteins. Immunisation to donor red cell antigensmay occur because o the presence o small but variable numbers o red cells inplatelet units. When Rh(D) positive platelets are transused to an Rh(D) negative

emale o child bearing potential, prevention o Rh(D) immunisation by use o Rh(D)Immunoglobulin should be considered. Usually 250 IU o Rh(D) Immunoglobulingiven intramuscularly per therapeutic platelet dose provides sufcient cover. Iintravenous Rh(D) Immunoglobulin administration is required, WinRho SDFTMshould be used. Transuse platelets through an intravenous line approved orblood administration and incorporating a clean standard (170 to 200m) flter.Transusion o each unit may proceed as ast as tolerated but should be completedwithin our hours o commencing transusion. The number o platelet pools to beadministered depends on the clinical situation o each patient. One unit o PlateletsPooled Leucocyte Depleted would be expected to increase the platelet count oa 70kg adult by 20-40 x 109/L. The usual dose in an adult patient is 1 pool. For

prophylaxis, this dose may need to be repeated in 1-3 days because o the shortlie span o transused platelets. Both immune and non-immune mechanisms maycontribute to reduced platelet recovery and survival.


Modifcations CMV-seronegative; Irradiated. Reer to Appendix III: Clinical indications ormodifed blood components (page 42-44).

Comments As or Platelets Apheresis Leucocyte Depleted (page 18-19).

PLATELETS Pooled Leucocyte Depleted

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Description Fresh Frozen Plasma (FFP) is separated and rozen within eighteen hours ater collectiono whole blood. FFP is also prepared rom anticoagulated blood which is separated intocomponents by a suitable apheresis machine with retention o the plasma and return

o the remaining elements to the donor. The apheresis plasma is then divided into twounits o equal volume and reezing commenced within six hours o collection. A unit oFFP contains all coagulation actors including approximately 200 IU o Factor VIII plusthe other labile plasma coagulation actor, Factor V.

Indications FFP is indicated or patients with a coagulopathy who are bleeding or at risk o bleedingwhere a specifc therapy such as vitamin K or actor concentrate is not appropriate orunavailable. FFP may be indicated in bleeding patients who require replacement olabile plasma coagulation actors such as in massive transusion, cardiac bypass,liver disease or acute disseminated intravascular coagulation (DIC). It also may beindicated in cases o wararin overdose with lie threatening bleeding in addition toProthrombin Complex Concentrates (vitamin K dependent actor concentrates e.g.Prothrombinex-VF)8. FFP or cryo-depleted plasma (CDP) may be indicated or patientswith thrombotic thrombocytopenic purpura (TTP).

Contraindications Do not use FFP when coagulopathy can be corrected more eectively with specifctherapy, such as vitamin K, cryoprecipitate, actor VIII or other specifc actorconcentrates. Do not use FFP when blood volumes can be saely and adequatelyreplaced with other volume expanders such as 0.9% Sodium Chloride Injection,Hartmanns Solution, or appropriate colloids.

Specifcation Volume 250-334mL; FVIIIc > 0.7 IU/mL.

Availability Available in all ABO groups.

Shel lie, storage 12 months at -25oC or below.

Dosage andadministration

Compatibility tests beore transusion are not necessary. Plasma should be ABO groupcompatible with the recipients red cells. However, i necessary ABO-incompatibleplasma can be used with caution. Group O plasma should be restricted to known groupO recipients. Group AB plasma can be saely transused to recipients o all blood groups.Matching or Rh(D) type is not necessary. The volume transused depends on the clinicalsituation and patient size, and should be guided by laboratory assays o coagulationunction. Thaw using an approved method. (Reer to Administration methods, page9-10.) Once thawed, FFP should be transused immediately or stored at 2-6oC or up to 24hours9. I used to treat coagulopathies other than Factor VIII defciency, thawed FFP maybe allocated by a medical practitioner or a designated patient under his or her care andstored at 2-6oC or up to 5 days10. Mix thoroughly by inversion beore use and transusethrough an intravenous line approved or blood administration and incorporating astandard (170 to 200m) flter. Transusion o each unit may proceed as ast as toleratedbut should be completed within our hours o commencing transusion.


Modifcations IgA defcient; Low titre anti-T; Secretor. Reer to Appendix III: Clinical indications ormodifed blood components (page 42-44).

FRESH FROZEN PLASMA

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Description Plasma is separated rom a single unit o whole blood and then divided into our

packs o equal volume or the purpose o reducing donor exposure or small paediatric

transusions and to minimise product wastage. The paediatric size plasma packs are

rozen within eighteen hours ater collection o the whole blood. A unit o Paediatric

Clinical FFP contains all coagulation actors including the labile plasma coagulation

actors VIII and V.

Indications As or Fresh Frozen Plasma (page 23).

Contraindications As or Fresh Frozen Plasma (page 23).

Specifcation Volume 63-81mL; FVIIIc > 0.7 IU/mL.



Dosage and

administration

Compatibility tests beore transusion are not necessary. Plasma should be ABO group

compatible with the recipients red cells. Matching or Rh(D) type is not necessary. The

volume transused depends on the clinical situation and patient size, and should be

guided by laboratory assays o coagulation unction. Thaw using an approved method.

(Reer to Administration methods, page 9-10.) Once thawed, FFP should be transused

immediately or stored at 2-6oC or up to 24 hours9. I used to treat coagulopathies other

than Factor VIII defciency, thawed FFP may be allocated by a medical practitioner

or a designated patient under his or her care and stored at 2-6oC or up to 5 days10.

Mix thoroughly by inversion beore use and transuse through an intravenous line

approved or blood administration and incorporating a standard (170 to 200m) flter.

Transusion o each unit may proceed as ast as tolerated but should be completedwithin our hours o commencing transusion.


Modifcations None.

FRESH FROZEN PLASMA Paediatric

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Description Cryo-depleted Plasma (CDP) is the supernatant remaining ater cryoprecipitate has

been removed rom resh rozen plasma (FFP). It contains most clotting actors in

similar amounts to FFP but is defcient in Factor VIII, fbrinogen, von Willebrand Factor

(VWF) (the high molecular weight multimers are more thoroughly removed than the

smaller multimers), Factor XIII and fbronectin.

Indications CDP is recommended or plasma exchange in thrombotic thrombocytopenic

purpura (TTP). It may also be used as an alternative to FFP or the treatment o

coagulopathy where there is no signifcant reduction in Factor VIII, fbrinogen,

Factor XIII, or VWF, e.g. it may be used or rapid temporary wararin reversal in

patients requiring emergency surgery and in wararin overdose with lie threatening

bleeding in addition to Prothrombin Complex Concentrates (vitamin K dependent

actor concentrates e.g. Prothrombinex-VF). For extended wararin reversal, vitamin

K may be recommended.

Contraindications Do not use CDP when coagulopathy can be corrected more eectively with specifc

therapy, such as vitamin K or specifc actor concentrates. Do not use CDP when blood

volumes can be saely and adequately replaced with other volume expanders such as

0.9% Sodium Chloride Injection, Hartmanns Solution, or appropriate colloids.

Specifcation Volume 215-280mL.



Dosage and

administration

Compatibility tests beore transusion are not necessary. CDP should be ABO group

compatible with the recipients red cells. However, i necessary ABO-incompatibleCDP can be used with caution. Group O plasma should be restricted to known group O

recipients. Group AB plasma can be saely transused to recipients o all blood groups.

Matching or Rh(D) type is not necessary. The volume transused depends on the clinical

situation. Thaw using an approved method. (Reer to Administration methods, page

9-10.) Once thawed, CDP should be inused immediately or allocated by a medical

practitioner or a designated patient under his or her care and stored at 2-6 oC or up to

5 days (unpublished ARCBS data). Mix thoroughly by inversion beore use and transuse


a standard (170 to 200m) flter. Transusion o each unit may proceed as ast as

tolerated but should be completed within our hours o commencing transusion.


Modifcations None.

CRYO-DEPLETED PLASMA

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Description Cryo-depleted Plasma Apheresis is the supernatant remaining ater cryoprecipitate

has been removed rom apheresis resh rozen plasma (apheresis FFP). It contains

most clotting actors in similar amounts to apheresis FFP but is defcient in Factor VIII,

fbrinogen, VWF (the high molecular weight multimers are more thoroughly removed

than the smaller multimers), Factor XIII and fbronectin.

Indications As or Cryo-depleted Plasma (page 25).

Contraindications As or Cryo-depleted Plasma (page 25).

Specifcation Volume 550mL + 10%.



Dosage andadministration Compatibility tests beore transusion are not necessary. CDP should be ABO groupcompatible with the recipients red cells. However, i necessary ABO-incompatible

CDP can be used with caution. Group O plasma should be restricted to known group

O recipients. Group AB plasma can be saely transused to recipients o all blood

groups. Matching or Rh(D) type is not necessary. The volume transused depends

on the clinical situation. Thaw using an approved method. (Reer to Administration

methods, page 9-10.) Once thawed, CDP should be inused immediately or allocated

by a medical practitioner or a designated patient under his or her care and stored at

2-6oC or up to 5 days (unpublished ARCBS data). Mix thoroughly by inversion beore

use and transuse through an intravenous line approved or blood administration

and incorporating a standard (170 to 200m) flter. Transusion o each unit may

proceed as ast as tolerated but should be completed within our hours o commencingtransusion.


Modifcations None.

CRYO-DEPLETED PLASMA Apheresis

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Description Cryoprecipitate is prepared by thawing resh rozen plasma (FFP) between 1oC and

6oC and recovering the precipitate. The cold-insoluble precipitate is rerozen. The

component contains most o the Factor VIII, fbrinogen, Factor XIII, VWF and fbronectin

rom the FFP.

Indications Cryoprecipitate is indicated in the treatment o fbrinogen defciency or

dysfbrinogenaemia when there is clinical bleeding, an invasive procedure, trauma or

disseminated intravascular coagulation (DIC).

Contraindications Cryoprecipitate should not be used or the treatment o haemophilia, von Willebrands

disease or defciencies o Factor XIII or fbronectin unless alternative therapies are

unavailable.

Specifcation Volume 30-40mL; Fibrinogen > 140mg/unit; FVIIIc > 70 IU/unit; VWF > 100 IU/unit.



Dosage and

administration

Compatibility tests beore transusion are not necessary. Preerably ABO group

compatible with the recipients red cells; however ABO-incompatible cryoprecipitate

can be used with caution, particularly with large volumes. I a large volume o ABO-

incompatible cryoprecipitate is used, the recipient may develop a positive direct

antiglobulin test (DAT) and, very rarely, mild haemolysis. Matching or Rh(D) type is

not necessary. The volume transused depends on the clinical situation and patient

size, and should be guided by laboratory assays o coagulation actors. Thaw using

an approved method. (Reer to Administration methods, page 9-10). Once thawed,

cryoprecipitate should be used within 6 hours i it is a closed single unit, or within4 hours i it is an open system or units have been pooled9. Thawed cryoprecipitate

should be maintained at 20-24oC until transused11. For pooling, the precipitate in

each concentrate should be mixed well with 10-15mL o diluent to ensure complete

removal o all material rom the container. The preerred diluent is 0.9% Sodium

Chloride Injection (USP). Mix thoroughly by inversion beore use and transuse


a standard (170 to 200m) flter. Transusion o each unit may proceed as ast as

tolerated but should be completed within our hours o commencing transusion.

In the steady state, the hal-lie o fbrinogen is 3-5 days. Dosing schedules

o cryoprecipitate inusions every 3 days may be appropriate or patients with

congenital hypofbrinogenemia.


Modifcations None.

CRYOPRECIPITATE

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Description Cryoprecipitate Apheresis is prepared by thawing apheresis resh rozen plasma

(apheresis FFP) between 1oC and 6oC and recovering the precipitate. The cold-insoluble

precipitate is rerozen. The component contains most o the Factor VIII, fbrinogen,

Factor XIII, VWF and fbronectin rom the apheresis FFP. One unit o Cryoprecipitate

Apheresis is approximately equivalent to two units o whole blood derived

Cryoprecipitate.

Indications As or Cryoprecipitate (page 27).

Contraindications As or Cryoprecipitate (page 27).

Specifcation Volume 60mL 10%; Fibrinogen > 140mg/unit; FVIIIc > 70 IU/unit; VWF > 100 IU/unit.



Dosage and

administration

Compatibility tests beore transusion are not necessary. Preerably ABO group

compatible with the recipients red cells; however ABO-incompatible cryoprecipitate

can be used with caution, particularly with large volumes. I a large volume o ABO-

incompatible cryoprecipitate is used, the recipient may develop a positive DAT and,

very rarely, mild haemolysis. Matching or Rh(D) type is not necessary. The volume

transused depends on the clinical situation and patient size, and should be guided

by laboratory assays o coagulation actors. Thaw using an approved method.

(Reer to Administration methods, page 9-10). Once thawed, cryoprecipitate should

be used within 6 hours i it is a closed single unit, or within 4 hours i it is an open

system or units have been pooled9. Thawed cryoprecipitate should be maintained at

20-24o

C until transused11

. For pooling, the precipitate in each concentrate shouldbe mixed well with 10-15mL o diluent to ensure complete removal o all material

rom the container. The preerred diluent is 0.9% Sodium Chloride Injection (USP).

Mix thoroughly by inversion beore use and transuse through an intravenous line

approved or blood administration and incorporating a standard (170 to 200m)

flter. Transusion o each unit may proceed as ast as tolerated but should be

completed within our hours o commencing transusion. In the steady state, the

hal-lie o fbrinogen is 3-5 days. Dosing schedules o cryoprecipitate inusions

every 3 days may be appropriate or patients with congenital hypofbrinogenemia.


Modifcations None.

CRYOPRECIPITATE Apheresis

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Appendix l: Red blood cells

CLINICAL PRACTICE GUIDELINES

Appropriate Use of Red Blood Cells

As well as a record of the clinical or laboratory indicationsfor the use of blood components, other relevant data couldinclude: reasons for giving blood components if not inaccordance with the guidelines (eg if red blood cells aregiven when the haemoglobin level is >100g/L); and otherrelevant medical history of the patients condition.

In all situations where blood component therapy is

given, a process for clinical review should be in placeto monitor the appropriateness and safety of its use

and to develop systems for the implementation of these

guidelines.

Clinical review groups or transfusion committees shouldinclude senior representatives of relevant clinical specialtiesand administration, nurses, blood bank and staff involvedin quality improvement. In larger hospitals this is likely tobe a separate committee. However, this is not necessaryand in smaller hospitals, the role could be undertakenby the medical advisory committee or through a localgeographic or organisational network.

As part of the informed consent process, a patient

should be given clear explanation of the potential

risks and benefits of blood component therapy in his

or her situation.

Community concern about blood issues and the safetyof blood component therapy makes the considerationof consumer issues and processes for informedconsent particularly important. Change at clinicaland organisational levels within hospitals will help tostandardise the use of blood components. Consumers canalso be important drivers of change to practice, if they areaware of the issues surrounding use of blood componentsand know about the risks and benefits in their ownsituation.

Contact Details

This document is one in a series of documents developedby the NHMRC/ASBT about the use of blood components.These documents are available from:

NHMRC Website at: http: //www.nhmrc.gov.au, orASBT Website at: http://www.asbt.org.auPrint copies of all documents can be obtained by emailing:

HEALTH ADVISORY CTTEE [email protected] by telephoning (02) 6289 9520 (24hr answeringmachine) or 1800 020 103. Alternatively you cancontact the ASBT by telephoning (02) 9256 5456 oremailing to the [email protected].

Summary of NHMRC/ASBT guidelines

This summary is derived from the National Health andMedical Research Council (NHMRC)/Australasian Societyof Blood Transfusion (ASBT) Clinical Practice Guidelineson the Use of Blood Components(red blood cells,platelets, fresh frozen plasma and cryoprecipitate). The

guidelines were produced in cooperation with theCommonwealth Department of Health and Aged Care,the Royal Australasian College of Surgeons, the Australianand New Zealand College of Anaesthetists, and otherrelevant groups. The coalition of organisations involvedin developing the guidelines demonstrates the degree ofinterest across the specialties in promoting the appropriateuse of blood components.

The recommendations included in this summary have beenendorsed by the NHMRC and the ASBT. The recommend-ations aim to support:

clinical decisions about the use of red cells; and quality processes to promote appropriate use of blood

components and optimise patient outcomes.

The clinical recommendations are summarised overleaf.For further details, consult the NHMRC/ASBT guidelines.

Organisational practice

Changing organisational practice through qualityimprovement is as important as changing clinical practice.A quality management system that includes monitoring,assessment, action and evaluation will allow audit of usageat the local level and eventual evaluation of changes inpractice and effect on health outcomes.

Documentation used in ordering or administering blood

components (eg request forms or blood administration

forms) should summarise the clinical recommendations

of these guidelines and collect standardised dataitems. Clinical and laboratory indications for blood

components should be accurately recorded in that

documentation and in the patients medical record.

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Appendix l: Red blood cells continued

Specific factors to consider

Patients cardiopulmonary reserve if pulmonaryfunction is not normal, it may be necessary to considertransfusing at a higher threshold.

Volume of blood loss clinical assessment shouldattempt to quantify the volume of blood loss before,during and after surgery, to ensure maintenance ofnormal blood volume.

Oxygen consumption this may be affected by anumber of factors including fever, anaesthesia andshivering; if increased then the patients need for redblood cell transfusion could be higher.

Atherosclerotic disease critical arterial stenosisto major organs, particularly the heart, may modifyindications for the use of red blood cells.

* Note that the rates of non-infective complications are probably higher than those of infective complications.Adapted from WHO (1998) Transfusion Today38: 36.Abbreviations: Hb = haemoglobin

In deciding whether to transfuse red blood cells, the patients haemogolobin level, although important, should not be thesole deciding factor. Patient factors, signs and symptoms of hypoxia, ongoing blood loss, the risk to the patient of anaemiaand the risk of transfusion should be considered.

Appropriate Use of Red Blood Cells

1 What improvement in the patients condition am I

aiming to achieve?

2 Can I minimise blood loss to reduce the patients

need for transfusion?

3 Are there any other treatments I should give

before making the decision to transfuse?

4 Have cross-matching and any other relevant testsbeen carried out?

5 What are the specific clinical or laboratory

indications for red blood cells for this patient?

6 What are the risks of transmitting infectious

agents through the available blood products?*

Prescribing blood components: checklist for clinicians

Decisions should be based on the NHMRC/ASBT Clinical Practice Guidelines for the Use of Blood Components, takingindividual patient needs into account. Before prescribing red blood cells, ask yourself the following questions.

7 Do the benefits of transfusion outweigh the risks

for this particular patient?

8 Will a trained person monitor this patient and

respond immediately if any acute transfusion

reactions occur?

9 Have I recorded my decision to transfuse and

reasons for transfusion on the patients chart

and any documentation used in the ordering oradministering of blood components?

10 Has the patient been given a clear explanation

of the potential risks and benefits of blood

component therapy in his or her particular case?

Reprinted July 2005 ISBN 1864960418 October 2001

ConsiderationsHb*

80g/L May be appropriate to control anaemia-related symptoms in a patient on a chronic transfusion regimen or

during marrow suppressive therapy.

>100g/L Not likely to be appropriate unless there are specific indications.

* The use of red blood cells for indications not listed in this table is unlikely to be considered appropriate as prophylaxis ortherapy. Consult the NHMRC/ASBT guidelines for further details. Clinical and laboratory indications should be documented.

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Appendix l: Platelets

Contact Details


NHMRC Website at: http://www.nhmrc.gov.au, orASBT Website at: http://www.asbt.org.auPrint copies of all documents can be obtained by emailing:


CLINICAL PRACTICE GUIDELINES

Appropriate Use of Platelets


This summary is derived from the National Health andMedical Research Council (NHMRC)/Australasian Societyof Blood Transfusion (ASBT) Clinical Practice Guidelineson the Use of Blood Components(red blood cells, platelets,fresh frozen plasma and cryoprecipitate). The guidelines

were produced in cooperation with the CommonwealthDepartment of Health and Aged Care, the RoyalAustralasian College of Surgeons, the Australian andNew Zealand College of Anaesthetists, and other relevantgroups. The coalition of organisations involved indeveloping the guidelines demonstrates the degree ofinterest across the specialties in promoting the appropriateuse of blood components.


clinical decisions about the use of platelets; and

quality processes to promote appropriate use ofblood components and optimise patient outcomes.

The clinical recommendations are summarised overleaf.For further details, consult the NHMRC/ASBT guidelines.



Documentation used in ordering or administering

blood components (eg request forms or blood

administration forms) should summarise the

clinical recommendations of these guidelinesand collect standardised data items. Clinical and

laboratory indications for blood components should

be accurately recorded in that documentation and in

the patients medical record.

As well as a record of the clinical or laboratory indicationsfor the use of blood components, other relevant data couldinclude: reasons for giving blood components if not inaccordance with the guidelines (eg if platelets are givenas prophylaxis when the platelet count is >20x109/L); andother relevant medical history of the patients condition.

In all situations where blood component therapy is

given, a process for clinical review should be in placeto monitor the appropriateness and safety of its use

and to develop systems for the implementation of

these guidelines.

Clinical review groups or transfusion committees shouldinclude senior representatives of relevant clinical specialtiesand administration, nurses, blood bank and staff involvedin quality improvement. In larger hospitals this is likely tobe a separate committee. However, this is not necessaryand in smaller hospitals, the role could be undertakenby the medical advisory committee or through a localgeographic or organisational network.


should be given clear explanation of the potential

risks and benefits of blood component therapy in his

or her situation.

Community concern about blood issues and the safetyof blood component therapy makes the considerationof consumer issues and processes for informed consentparticularly important. Change at clinical and organisationallevels within hospitals will help to standardise the useof blood components. Consumers can also be importantdrivers of change to practice, if they are aware of the issuessurrounding use of blood components and know about therisks and benefits in their own situation.

SSummary ofummary ofNNHMHMRRC/C/ASASBBTT guidelinesguidelines

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Appendix l: Platelets continued


Use of platelets is indicated for the prevention and treatment of haemorrhage in patients with thrombocytopenia or plateletfunction defects. The platelet count is the primary trigger for the use of platelets, with clinical risk factors for bleeding and the

extent of bleeding also influencing the decision to transfuse.

Indication* ConsiderationsBleeding May be appropriate in any patient in

whom thrombocytopenia is considered amajor contributory factor.

Massive Use should be confined to patients withhaemorrhage/ thrombocytopenia and/or functionaltransfusion abnormalities who have significant bleeding

from this cause. May be appropriate whenthe platelet count is

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Appendix l: Fresh rozen plasma and cryoprecipitate


This summary is derived from the National Healthand Medical Research Council (NHMRC)/AustralasianSociety of Blood Transfusion (ASBT) Clinical PracticeGuidelines on the Use of Blood Components(red blood

cells, platelets, fresh frozen plasma and cryoprecipitate).The guidelines were produced in cooperation with theCommonwealth Department of Health and Aged Care,the Royal Australasian College of Surgeons, the Australianand New Zealand College of Anaesthetists, and otherrelevant groups. The coalition of organisations involvedin developing the guidelines demonstrates the degree ofinterest across the specialties in promoting the appropriateuse of blood components.


clinical decisions about the use of fresh frozen plasmaand cryoprecipitate; and

quality processes to promote appropriate use of bloodcomponents and optimise patient outcomes.

The clinical recommendations are summarised overleaf. Forfurther details, consult the NHMRC/ASBT guidelines.



Documentation used in ordering or administering

blood components (eg request forms or blood

administration forms) should summarise theclinical recommendation of these guidelines

and collect standardised data items. Clinical and

laboratory indications for blood components

should be accurately recorded in that document-

ation and in the patients medical record.

As well as a record of the clinical or laboratory indicationsfor the use of blood components, other relevant data couldinclude: reasons for giving blood components if not inaccordance with the guidelines (eg if fresh frozen plasmais given when there is no evidence of bleeding or abnormalcoagulation); and other relevant medical history of thepatients condition.

In all situations where blood component therapy

is given, a process for clinical review should be

in place to monitor the appropriateness and

safety of its use and to develop systems for the

implementation of these guidelines.

Clinical review groups or transfusion committees shouldinclude senior representatives of relevant clinical specialtiesand administration, nurses, blood bank and staff involved inquality improvement. In larger hospitals this is likely to bea separate committee. However, this is not necessary andin smaller hospitals, the role could be undertaken by themedical advisory committee or through a local geographicor organisational network.


should be given clear explanation of the potentialrisks and benefits of blood component therapy in

his or her situation.

Community concern about blood issues and the safetyof blood component therapy makes the considerationof consumer issues and processes for informed consentparticularly important. Change at clinical and organisationallevels within hospitals will help to standardise the useof blood components. Consumers can also be importantdrivers of change to practice, if they are aware of the issuessurrounding use of blood components and know about therisks and benefits in their own situation.

Contact Details


NHMRC Website at: http: //www.nhmrc.gov.au, orASBT Website at: http://www.asbt.org.auPrint copies of all documents can be obtained by emailing:


CLINICAL PRACTICE GUIDELINESAppropriate Use of Fresh Frozen Plasma and Cryoprecipitate

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Appendix l: Fresh rozen plasma and cryoprecipitate continuedAppropriate Use of Fresh Frozen Plasma and Cryoprecipitate

Fresh frozen plasma is frequently used inappropriately, either in respect of the particular indication or in excessive quantity

for a given indication. There are also a number of clinical situations in which the use of fresh frozen plasma has beenadvocated but has not been shown to be of benefit or alternative therapies are equally satisfactory or safer.

As there is little scientific evidence regarding the effectiveness of cryoprecipitate in improving clinical outcomes, andspecific factor concentrates are now widely available, its use should be limited to selected indications.

Use ofFFPis likely to be appropriate for:

Indication* Considerations

Single factor Use specific factors if available.

deficiencies

Warfarin effect In the presence of life-threatening

bleeding. Use in addition to

vitamin-K-dependent concentrates.

Acute DIC Indicated where there is bleeding

and abnormal coagulation. Not

indicated for chronic DIC.TTP Accepted treatment.

Coagulation inhibitor May be appropriate in patients

undergoing high-risk

procedures. Use specific factors if

available.

Following massive May be appropriate in the presence

transfusion or cardiac of bleeding and abnormal

bypass coagulation.

Liver disease May be appropriate in the

presence of bleeding andabnormal coagulation.

Use ofcryoprecipitate is likely to be appropriate for:

Indication* Considerations

Fibrinogen deficiency May be appropriate where there isclinical bleeding, an invasiveprocedure, trauma or DIC.

DIC Fibrinogen deficiency iscommonly encountered in DIC.At fibrinogen levels lower than1.0g/L and where there is clinicalbleeding, use of cryoprecipitate to

keep fibrinogen levels above1.0g/L may be indicated.

Contraindications

The use offresh frozen plasmais generally notconsidered appropriate in cases of

hypovolaemia,

plasma exchange procedures or

treatment of immunodeficiency states.

Unless alternative therapies are unavailable, the use ofcryoprecipitate is not generally considered appropriate inthe treatment of:

haemophilia

von Willebrands disease, or deficiencies of factor XIII or fibronectin.

* The use of fresh frozen plasma or cryoprecipitate for indicationsnot listed in these tables is unlikely to be considered appropriate.Consult the NHMRC/ASBT guidelines for further details. Clinical

and laboratory indications should be documented.

Note: Abnormal coagulation is defined here as greater than 11.5

times normal range.

1 What improvement in the patients condition am I

aiming to achieve?

2 Can I minimise blood loss to reduce the patients

need for transfusion?

3 Are there any other treatments (such as specific

or combined factor concentrates) that would be

more appropriate and safer?

4 What are the specific clinical or laboratory

indications for fresh frozen plasma or

cryoprecipitate for this patient?

5 What are the risks of transmitting infectious

agents through the available blood products?*

6 Do the benefits of transfusion outweigh the risks

for this particular patient?

7 What other options are there if no fresh frozen

plasma or cryoprecipitate is available in time?

8 Will a trained person monitor this patient and

respond immediately if any acute transfusion

reactions occur?

9 Have I recorded my decision to transfuse and

reasons for transfusion on the patients chart

and any documentation used in the ordering oradministering of blood components?

10 Has the patient been given a clear explanation

of the potential risks and benefits of blood

component therapy in his or her particular case?

Decisions should be based on the NHMRC/ASBT Clinical Practice Guidelines for the Use of Blood Components, taking individualpatient needs into account. Before prescribing fresh frozen plasma or cryoprecipitate, ask yourself the following questions.


* Note that the rates of non-infective complications are probably higher than those of infective complications.Adapted from WHO (1998) Transfusion Today38: 36.Abbreviations: DIC = disseminated intravascular coagulation; TTP = thrombotic thrombocytopenic purpura

ISBN 1864960477 October 2001

deficiencies

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Appendix ll: Adverse reactions

Adverse reaction Clinical considerations

Allergic Usual aetiology:Allergy to plasma proteins, rarely to donor medication etc.Incidence:1-3% o transusions3,12.

Main clinical features:Usually pruritic urticarial lesions, but may also

include wheezing or angioedema.

Investigation:Usually none.

Intervention:Stop or slow transusion. Give antihistamine. In severe cases

consider corticosteroids or adrenaline. Transusion can be continued at

a slower rate when the reaction abates. Consider premedication and/or

washed cells i recurrent.

Anaphylactoid

reactionsor anaphylaxis

Usual aetiology:The majority o these reactions have been reported in IgA

defcient patients who have antibodies against lgA o the IgE class. Also IgE-mediated allergy to other plasma proteins, rarely to donor medication etc.

Incidence:1:20,000-50,000 transusions3,12.

Main clinical features:May be atal. Onset characterised by coughing,

bronchospasm, laryngospasm, respiratory distress, vascular instability,

nausea, abdominal cramps, vomiting, diarrhoea, shock and loss o

consciousness.

Investigation:Check recipient pre-transusion sample or IgA defciency

and presence o antibodies against lgA.

Intervention:Stop transusion immediately. Maintain airway and

intravenous line. Administer adrenaline and corticosteroids. Treathypotension. Inorm ARCBS. Where appropriate, use autologous, washed or

components rom IgA defcient donors i uture transusion required.

Circulatory overload

(oten reerred to as

transusion-associated

circulatory overload

(TACO))

Usual aetiology:Volume overload usually due to rapid or massive

transusion o blood in patients with diminished cardiac reserve or

chronic anaemia.

Incidence:Up to 1% o patients receiving transusions3,12.

Main clinical features:Dyspnoea, orthopnea, cyanosis, tachycardia,

increased blood pressure and pulmonary oedema.

Investigation:Clinical assessment.

Intervention:Stop transusion and treat symptoms with oxygen, diuretictherapy and upright position. In susceptible patients, transusion should

be administered slowly and in the most concentrated orm possible.

(Continued next page)

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Appendix ll: Adverse reactions continued


Febrile non-haemolytictransusion reaction Usual aetiology:Alloimmunisation to donor HLA or other antigens. Cytokineaccumulation during storage.

Incidence:: 0.1-1% o transusions with universal leucocyte depletion3.

Most requently in patients previously alloimmunised by transusion or

pregnancy.

Main clinical features:Temperature rise o >1C during or shortly ater

transusion and in the absence o any other pyrexic stimulus. Chills, rigors

and headache.

Investigation:Clinical assessment.

Intervention:Consider and exclude other causes. Give antipyretic.

Haemolysis: acuteintravascular

Usual aetiology:Immunologic destruction o transused red cells, nearlyalways due to incompatibility o antigen on the transused cells with

antibody in the recipient circulation. Most common cause is transusion

o ABO-incompatible blood. Rarely due to physical or chemical damage to

transused red cells e.g. eects o drugs co-administered with transusion,

eects o bacterial toxins, thermal injury due to reezing or overheating or

transusion o red cell antibodies.

Incidence:Variably reported or ABO incompatibility as 1:12,000-77,00012.

Main clinical features:Characteristically begins with an increase in

temperature and pulse rate; symptoms may include chills, dyspnoea, chest

or back pain, abnormal bleeding or shock. Instability o blood pressure isrequent. In anaesthetised patients, hypotension and evidence o DIC may

be the frst sign.

Investigation:Clinical assessment. Clerical check o ABO typing o patient

and unit. Perorm direct antiglobulin test (DAT) and indirect antiglobulin

test (IAT), renal unction, tests or haemolysis (e.g. urinary haemoglobin)

etc.

Intervention:Stop transusion immediately. Maintain blood pressure and

renal output. Seek urgent assistance. Inorm the laboratory responsible or

dispensing blood or transusion. Inorm ARCBS.

(Continued next page)

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Appendix ll: Adverse reactions continued


Haemolysis: delayed(usually extravascular) Usual aetiology:Usually occurs in previously red cell alloimmunisedpatients in whom antigens on tr

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