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PLATELET CONCENTRATESCan be produced during the routine conversion of whole blood intoconcentrated rbcs or by apheresis
essential for the formation of the primary hemostatic plug and
maintenance of normal hemostasis
FOR :
Actively bleeding patients (thrombocytopenic, less than 50 x
109/L due to decreased production or decreased function)
Cancer patients during radiation and chemotherapy because of
induced thrombocytopenia ( less than 20 x 109/L)
Thrombocytopenia preoperative patients (less than 50 x 109/L)
Not usually indicated for patients with DIC or idiopathic
thrombocytopenic purpura (ITP)
PLATELET CONCENTRATESRandom-donor platelets
Prepared from whole blood
Should contain at least 5.5 x 1010
Stored at 20 24OC with continuous agitation
Contain sufficient plasma to yield a pH of greater than or equal to 6.2
Shelf life 5 days
Single-donor platelets
prepared from apheresis
Contain at least 3.0 x 1011
Stored at 22 24OC with agitation
Contain approx. 300 ml of plasma
Shelf-life 5 days
PLATELET CONCENTRATES
Single-donor platelets
Generally indicated for patients who are unresponsive to randomplatelets due to HLA alloimmunization
To limit the platelet exposure from multiple donors
Platelet concentrate preparation
prepared within 6 hoursof collection
Centrifuge whole blood (set at 22OC) light spin 3200 rpm for 2 to 3
minutes
Platelet rich plasma is expressed into one of the satellite bags
Disconnect rbc and store it at 4OC
Recentrifuge PRP at 22OC using a heavy spin 3600 rpm for 5
minutes
Express majority of the plasma into the second satellite bag
PLATELET CONCENTRATES
Platelet concentrate preparation prepared within 6 hours
of collection
Leave approx. 50 70 ml of plasma on the platelets
To maintain a pH of 6.2 during storage
Plasma
stored as FFP, single-donor plasma frozen within 24 hours(PF24) or liquid recovered plasma
Platelet concentrate lie undisturbed for 1 to 2 hours at 20 24OC,
making sure the platelet button is covered with plasma
Shelf-life is 5 days from the date of collection
If open system, transfusion must occur within 6 hours
Label properly (volume, expiration date and time)
All units for a single dose ( 6 to 8 units) must be pooled and must be
transfused within 4 hours of pooling
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PLATELET CONCENTRATESQUALITY CONTROL PROCEDURES (monthly)
Platelet count (random-donor 5.5 x 1010 and single-donor
3.0 x 1011)
Volume must be sufficient to maintain an acceptable pH until the
end of the dating period
methods in place to limit and detect bacterial contamination in
platelet components
improved phlebotomy techniques
culture and staining methods to detect bacterial organisms
dipsticks to detect bacterial levels
a swirling technique to detect metabolic changes in platelets
Can be irradiated, leukocyte-reduced or washed
PLATELET ALIQUOTSIndicated for neonates whose counts fall below 50,000/mL and
who are experiencing bleeding
Factors that may be associated with thrombocytopenia:
1. immaturity of the coagulation system
2. platelet dysfunction
3. increased destruction of platelets
4. dilution effect secondary to massive transfusion or exchange
5. Transfusion
6. intraventricular hemorrhage
Either random or apheresed platelets may be transfused
Expiration: 4 hours
PLATELETS LEUKOREDUCEDPURPOSE OF LEUKOREDUCTION:
1. Prevention of febrile nonhemolytic reactions
2. Prevent or delay the development of HLA antibodies
3. Reduce the risk of transmission of CMV
must contain less than 8.3 x 105 leukocytes
If the platelets have been pooled, a method must be used that
results in a leukocyte count of less than 5 x106 in the final
pooled product
Single-donor or apheresis platelets that have been leukoreduced
must contain less than 5 x 106 leukocytes in at least 95% of units
tested
GRANULOCYTES PHERESISFor Patients who have received:
intensive chemotherapy for leukemia
bone marrow transplant, OR BOTH
CRITERIA:
those with fever, neutrophil counts less than 500/mL
septicemia or bacterial infection unresponsive to antibiotics
reversible bone marrow hypoplasia
a reasonable chance for survival
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GRANULOCYTES PHERESISAdults: usual dose is1 granulocyte pheresis product daily
for 4 or more days
For neonates, a portion of a granulocyte pheresis unit is
usually given once or twice
Granulocytes components should be administered as soonas possible and within 24 hours of collection
PLASMASeparated from cellular blood elements and frozen to preserve
the activity of labile coagulation factors
Plasma must be placed in the freezer within time framerequired for the anticoagulant or collection process
Stored at18OC
Cryoprecipitation is accomplished by slow thawing, at 1 to 6OC,
plasma that has been prepared for freezing within the time
frame required for the anticoagulant or collection process
Cryoprecipitate should be refrozen within 1 hour of thawing
Store at18 C or colder, preferably30 C or colder, for up to 12
months from the date of blood collection
SINGLE-DONOR PLASMA: FFPFrozen plasma from single donors may comprise FFP, PF24,
or plasma cryoprecipitate-reduced
Fresh frozen plasma (FFP)
produced from whole blood when obtained from a single,
uninterrupted nontraumatic venipuncture
plasma is frozen within 8 hours of collection (CPD, CD2D, or
CPDA-1
within 6 hours if the preservative was ACD
stored at18OC for 1 year or65OC for 7 years
contains maximum levels of labile and nonlabile clotting factors
about 1 IU per ml
SINGLE-DONOR PLASMAPlasma frozen within 24 hours after phlebotomy
(PF24/FP24)
frozen within 8 to 24 hours of collection
Stored at18OC
contains all stable proteins found in FFP
Both PF24 and FFP are thawed at temperatures between 30
and 37OC or in an FDA-approved microwave device
Product should be stored within 1 to 6OC for no more than 24 hours
(after thawing)
Indicated in patients who are actively bleeding and have multiple
clotting factor deficiencies
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SINGLE-DONOR PLASMAA single unit of FFP or PF24:
should contain 150 to 250 mL of plasma
approximately 400 mg of fibrinogen
1 unit of activity per mL of each of the stable clotting factors
FFP also contains the same level (1 unit/mL) of factors V and
VIII
Plasma cryoprecipitate reduced (cryopoor plasma)
Supernatant remaining from the production of cryoprecipitate
used exclusively in the treatment of thrombotic
thrombocytopenic purpura.
Cryoprecipitate has been removed from the plasma product and stored
at 18OC or colder, expiration is 1 year from date of collection
PLASMA AND LIQUID PLASMACan be prepared directly from whole blood or as a by-product of
platelet concentrate or cryoprecipitate production
Can be used as volume expanders or for the manufacturing of
plasma fractionation products such as:
plasma protein fraction (PPF)
normal serum albumin (NSA)
immune serum globulin (ISG)
Plasma in a unit of whole blood can be separated during storage and up
to 5 days after the expiration date
Stored at18OC or colder and labeled as plasma with a shelf-life of 5
years
can be transfused up to 5 days after the expiration date of the whole
blood
S/D POOLED PLASMAConsists of pools of no more than 2500 units of ABO type-
specific plasma
treated with solvent/detergent in the thawing process
to inactivate lipid-enveloped viruses such HIV and hepatitis B
Solvent tri-n-butyl phosphateDetergent triton X-100
Product volume is approximately 200 mL
Contains stable and labile clotting factors but lacks von Willebrands
factor multimers
Does not protect against the nonlipid enveloped viruses such as
hepatitis A and B19 parvovirus
CRYOPRECIPITATED ANTIHEMOPHILIC FACTORCold-precipitated concentration of factor VIII, the antihemophilic
factor (AHF)
Prepared from FFP thawed slowly (14 16 h)between 1 and 6OC
Suspended in less than 15 mL of plasma
Contains:
most of the factor VIII and part of the fibrinogen from the original
plasma
at least 80 units of AHF activity and at least 150 mg of fibrinogen
Others: factor XIII and von Willebrands factor
has a shelf-life of 12 months in the frozen state and must be
transfused within 6 hours of thawing or within 4 hours of pooling
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CRYOPRECIPITATED ANTIHEMOPHILIC FACTORLike FFP and PF24, cryoprecipitate should be thawed quickly at
37OC
Once thawed, store at room temperature (22 to 24O
C untiltransfused
Indicated in the treatment of:
1. Classic hemophilia (hemophilia A)
2. von Willebrands disease
3. Factor XIII deficiency and as a
4. source of fibrinogen for hypofibrinogenemia
Store at18C or colder up to 12 months from the date of whole
blood collection
CRYOPRECIPITATE
Constituents Amount
Factor VIII 80 120 U/concentrate
Fibrinogen 150 250 mg/concentrate
vWF 40 70% of original FFP
Factor XIII 20 30% of original FFP
Cold insoluble portion of plasma remaining after FFP has
been thawed at refrigerator temperatures
NOVOSEVEN Recombinant activated factor VII (NovoSeven, Denmark)
Induces hemostasis in life- and limb-threatening bleeds and in
major surgery of hemophilia A and B patients in the presence of
inhibitors
Factor VIIa binds to activated platelets and activates small
amounts of FX independent of tissue factor and that the platelet
surface FXa can restore platelet surface thrombin generation in
hemophilia
useful in hemophilia patients who have developed inhibitors to
factor VIII
FACTOR VIII CONCENTRATESUsed in the treatment of classic hemophilia and hemophilia
A and in persons deficient in factor VIII
Prepared from large volumes of pooled plasma or in the form
of recombinant FVIII using DNA technology
Techniques used to inactivate or eliminate viralcontamination:
1. Pasteurization
2. Solvent/detergent treatment
3. Monoclonal purification
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FACTOR VIII CONCENTRATES1. Pasteurization
Stabilizers such as albumin, sucrose, or glycine are added to the factorVIII concentrate to prevent denaturation of the product
Heated to 60OC for 10 hours
Stabilizers are removed, and the product is lyophilized
2. Solvent/detergent treatment
Use of ethyl ether and tri(n-butyl) phosphate and the detergent sodium
cholate and Tween 80
Removed then lyophilized
3. Monoclonal purification
Immunoaffinity chromatography
used to positively select out of pooled plasma the vWF:FVIII complex
PORCINE FACTOR VIII
Xenographic form of factor VIII
Made from porcine plasma
Beneficial for patients with hemophilia A who havedeveloped inhibitors or antibodies to human factor VIII
Shown to provide effective hemostatic control for patients
with intermediate FVIII inhibitor levels
Residual porcine vWF in the preparation of the product
induces platelet activation
Enhancing hemostasis apart from the action of circulating
FVIII
RECOMBINANT FACTOR VIIIProduction of recombinant human FVIII (rFVIII)
Synthesized by introducing human FVIII gene into BHK
(baby hamster kidney cells)
rFVIIIreleased into culture medium and harvested,
isolated, and purified using a combination of ion exchange
chromatography, gel filtration, and immunoaffinity
chromatography
Purification and final formulation Human albumin as a
stabilizer
Next generation : rFVIII:FS uses sucrose as final
stabilizer
FACTOR IX CONCENTRATESThree forms:
1. Prothrombin complex concentrates
contains significant levels of vitamin Kdependent factors: II, VII,
IX, and X
prepared from large volumes of pooled plasma by absorbing the
factors out using barium sulfate or aluminum hydroxide
lyophilized and virally inactivated
may contain activated vitamin Kdependent factors
2. Factor IX concentrates
developed by monoclonal antibody purification
less thrombogenic than prothrombin complex concentrates
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FACTOR IX CONCENTRATES2. Factor IX concentrates
contains approximately 20 to 30% of FIX
stored in the refrigerator in lyophilized form3. Recombinant factor IX (rFIX)
produced in a Chinese hamster ovary cell line and not thought to
transmit human infectious disease
treatment of patients with hemophilia B
FACTOR XIII CONCENTRATESFactor XIII deficiency a severe autosomal-recessive
bleeding disorder associated with a characteristic pattern of
neonatal hemorrhage and a lifelong bleeding diathesisThere are currently two plasma-derived virus inactivated
factor XIII concentrates:
1. Fibrogammin P
available in Europe, South America, South Africa, and Japan
2. Factor XIII concentrate (Bio Products Laboratory, Elstree,
UK)
UK
IMMUNE SERUM GLOBULINImmune globulin is indicated for:
1. Patients with immunodeficiency diseases (i.e. severe combined
immunodeficiency and Wiskott-Aldrich syndrome)
2. Providing passive antibody prophylaxis against hepatitis and
herpes
Concentrate of plasma gamma globulins in an aqueous
solution
Prepared from pooled plasma by cold ethanol fractionation
Administered IV or IM
Half-life of 18 to 32 days
IMMUNE SERUM GLOBULINIVIg is also used in patients with:
Idiopathic thrombocytopenic purpura
Post-transfusion purpura
HIV-related thrombocytopenia
Neonatal alloimmune thrombocytopenia (NAIT)
Contraindications:
Individuals with a history of IgA deficiency or anaphylactic
reactions should not receive immune globulin
because of the presence of trace amounts of IgA
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NORMAL SERUM ALBUMIN (NSA)Prepared from salvaged plasma
Pooled and fractionated by a cold alcohol process
Treated with heat inactivation (60O
C for 10 hours), whichremoves the risk of hepatitis or HIV infection
Composed of: 96% albumin and 4%globulin
Albumin used routinely as the replacement fluid in many
plasmapheresisprocedures
replacing the colloid that is removed during the procedures
Can be used with diuretics to induce diuresis in patients with low
total protein because of severe liver or protein-losing disease
NSAAvailable in 25% or 5% solutions
Intended for:
patients who are hypovolemic hypoproteinemic
In clinical settings of shock
burn patients
25%preparation is contraindicated in patients who are
dehydrated
unless it is followed with crystalloid infusions (e.g., normal saline)
for volume expansion
PLASMA PROTEIN FRACTION (PPF)Contains 83% albumin and 17% globulins
Similar in preparation with NSA with lesser purification steps
available in a 5% preparation
Similar use to that of NSA
contraindicated for infusion during cardiopulmonary bypass
procedures
PPF and NSA can be stored for 5 years at 2 to 10OC and
have not been reported to transmit HIV or hepatitis
RhO (D) IMMUNOGLOBULINRh immunoglobulin (RhIg) is a solution of concentrated anti-Rho(D)
prepared from pooled human plasma of patients who have
been hyperimmunized and contains predominantly IgG anti-D
Has 2 primary uses: (1) treatment of ITP and (2) prevention
of Rh HDN
During the first 12 weeks of pregnancy, a 50-mg dose of RhIg
is indicated for D-negative females for abortion or
miscarriage
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RhO (D) IMMUNOGLOBULINAfter 12 weeks gestation, a full dose (300 mg) is indicated
for abortion or miscarriage in D negative women
120-mg dose is advised after 34 weeks gestation: When amniocentesis is performed
In the event of obstetric complication or following termination of
pregnancy
RhIg is also used in the event Rh-positive components are
transfused to Rh-negative patients
A 300-g dose IM (120-mg dose IV) is sufficient to protect against D-
positive RBCs contained in 10 units of random platelets
SYNTHETIC VOLUME EXPANDERSTWO CATEGORIES:
1. Crystalloids
Ringers lactate consists of Na, Cl, K, Ca, and lactate ions
normal isotonic saline Na and Cl ions
2. Colloids
Dextran prepared in a 6 and 10% solution with a half-life of 6
hours
HES available in a 6% solution with an IV half-life of more than
24 hours
used as volume expanders in hemorrhagic shock and burn
patients
SYNTHETIC VOLUME EXPANDERSCHARACTERISTIC COLLOID CRYSTALLOID
Intravascular Retention Good Poor
Peripheral edema Possible Common
Pulmonary edema Possible PossibleEasily excreted No Yes
Allergic reactions Rare Absent
Cost Expensive Inexpensive
Examples Albumin
Dextran
Ringers lactate
solution
Hydroxyethyl starch 7.5% Normal saline
ANTITHROMBIN III CONCENTRATESAntithrombin-III concentrates (AT-III) or antithrombin (AT)
an inhibitor of clotting factors IX, X, XI, XII, and thrombin
prepared from pooled human plasma and heat-treated to
prevent viral transmissionfor treatment of patients with hereditary AT deficiency in
connection with surgical or obstetrical procedures
Or when they suffer from thromboembolism
rhAT is produced by transgenic goats expressing
recombinant human AT in their milk