Implementation and execution of civilian RDCR

programs – Minnesota RDCR

Donald H Jenkins, MD FACS Associate Professor of Surgery and Director of Trauma

Division of Trauma, Critical Care and Emergency General Surgery Saint Marys Hospital, Rochester MN

June 2013

Remote Damage Control: Civilian Experience in

the Pre-Hospital Setting

No Disclosures

Objectives

•  Indications for treatment with blood products for traumatic hemorrhagic shock in the pre-hospital setting

•  Monitoring devices used for coagulopathy and shock •  Therapeutics utilized in these patients for pre-hospital

treatment of casualties •  Evacuations of long durations compared to rapid ones •  Methods of implementation to improve rapid

incorporation of recently initiated changes in practice

Remote Damage Control Resusc

•  Austere/rural environment patients •  Modified transfusion strategy •  Different than those with scene/pre-hospital time < 30

minutes •  Limited resources available •  Lack of plasma availability •  40% of the population, 60% of the trauma mortality

•  Current treatment options for uncontrolled hemorrhage in this environment are very limited

•  >75% of combat fatalities occur in the field

Hartford Consensus February 2013

•  Leaders in law enforcement, EMS, military and the American College of Surgeons

•  Recommendations for civilian organizations to improve survival during active shooter scenarios

•  Stress “the importance of early and definitive hemorrhage control to maximize survival in the victims….”

Hartford Consensus THREAT •  T - Threat suppression •  H - Hemorrhage Control •  RE - Rapid Extraction to safety, •  A - Assessment by medical providers •  T - Transport to definitive care

Coagulopathy on Presentation

•  An initial INR ≥ 1.5 reliably predicts those military casualties who will require MT.

•  Pts who have a significant injury present with a coagulopathy.

•  Severity of injury and mortality is linearly associated with the degree of the initial coagulopathy.

- Schreiber MA, Perkins JP, Kiraly L, Underwood SJ, Wade CE, Holcomb JB. Early Predictors of Massive Transfusion in Combat Casualties. Submitted, J Trauma. - Brohi K, et al. Acute traumatic coagulopathy. J Trauma. 2003.

Background

MacLeod JBA et al. Early Coagulopathy Predicts

Mortality in Trauma J Trauma 2003

Brohi K et al. Acute Traumatic Coagulopathy

J Trauma 2003

By the time of arrival at the ED, 28% (2,994 of 10,790) of trauma patients had a detectable coagulopathy that was

associated with poor outcome

Background

de Biasi et al. Early Coagulopathy Predicts Mortality in Trauma

Transfusion (Epub, Accepted 2010)

Mortality was associated with worse Plasma Deficit &

The efficacy of the Plasma Repletion occurs within hours

DoD Learned About Thawed Plasma

•  Thawed plasma is FFP that is kept for up to 5 days at 4°C •  This product should be present upon arrival of the casualty in

the ED •  should be used as a primary resuscitative fluid started in the ED

•  This approach not only addresses the metabolic abnormality of shock, but initiates reversal of the coagulopathy present in the ED.

•  Thawed plasma is used in theater •  The DoD Level 1 trauma center uses this product

•  Decreases waste by 60-70%

- Malone DL, Hess JR, Fingerhut A. Comparison of practices around the globe and suggestion for a massive transfusion protocol. J Trauma, 2006. - Armand R, Hess JR. Treating coagulopathy in trauma patients. Transfus Med Rev 2003.

Early Use of Blood in the Pre-hospital Setting

•  Mayo Clinic Experience •  1993-96 retrospective review •  Criteria: Hgb<10, shock, hypotension after

resuscitation •  ~2100 helicopter flights, 94 patients received

PRBC’s (4%, 91% interfacility transfer) •  48% trauma patients, 25% GI bleed, 38% AAA •  Hgb increased from 8.9 to 10.2 after 2 PRBC •  No transfusion reactions or complications •  Average 12 u PRBC after admision •  Age of RBC is < 14 days

Air Med J 1998 Zietlow and Berns

Age of Blood and Procoagulant Microparticles

•  Historically, PCMP increases with age of blood

•  52 trauma patients vs 22 volunteers •  Higher PCMP with injury; no difference

between transfused (n=19)/not transfused •  24 hour PCMP decreased with transfusion

•  No decrease if no transfusion •  Difference widened with increasing transfusion

Spinella Crit Care 2009 Jy Transfusion 2011 Rubin Transfusion 2010-12

Catchment Area

Rationale Coagulopathy & the “Golden

Hour”

•  Trauma Induced Coagulopathy (TIC) predicts mortality

•  Plasma and RBC resuscitation should occur early in the hemorrhagic / coagulopathic pt

•  Catchment area / Rural location provides geographic obstacles

•  Regional plasma deficiency

Protocol – ED Phase •  Thawed Plasma Program •  Developed in Feb 2008 with input from:

- Blood Bank Team - Transfusion Medicine - Medical Transport - Trauma, Critical Care and General Surgery

•  Initial 9 months were restricted to in-hospital Emergency Department use

•  Medical and Surgical emergencies - Safety concerns - Utilization of resources

•  Product immediately available in the Trauma Resuscitation Area: - 4 units thawed plasma (A+) - 4 units PRBCs (0 negative)

•  Order of transfusion for trauma patients was: •  2 units PRBC •  2 units thawed Plasma •  2 units PRBC •  2 units thawed Plasma

Protocol – Helicopter Phase

pRBC + Plasma 1.  Hypotension (single reading

of systolic blood pressure < 90mmHg)

2.  Tachycardia (single reading of heart rate ≥ 120)

3.  Penetrating mechanism 4.  Point of care lactate ≥ 5.0

mg/dl 5.  Point of care INR ≥ 1.5

Indications for PRBC and Plasma administration in adult trauma patients

Plasma Alone 1.  Point of care INR ≥ 1.5 2.  Stable Hemodynamics

Waste Prevention Division of Transfusion Medicine monitors

usage

- Thawed plasma is removed from the satellite blood refrigerator on Day #3 and sent to the Operating Theater for immediate use.

Mayo Helicopter Transfusion Criteria

RESULTS

•  5 for hemorrhage •  3 required massive transfusion (> 10 units/24 hours)

•  5 pts transfused for history of trauma and coumadin use

•  All 4 deaths were in this group

•  All pts entered into protocol required ongoing blood product transfusion after arrival to the hospital.

10 TRAUMA PATIENTS TRANSFUSED IN FLIGHT 2/2009 – 9/2010

Trauma Patients (n=10)

Age (years) Male ISS

LOS (days) Mortality

71.5 [30-75.3] 8/10

25.5 [16.8-29.3] 4.5 [1.8-24.8]

4/10

Admission Laboratory Values Coumadin 5/10 (50%) Lactate 2.8 [1.7-5.7] Base -4.1 [-12.5- -0.5] PLT 149 [114-180] PTT 30 [28-42] HgB 10.8 [10.1-13.5] Post-Flight INR 1.6 [1.3-2.8] Pre-Flight INR 2.7 [1.6 – 4.0]

Feasibility

•  Excellent utilization •  No discarded units of plasma to date

•  No transfusion reactions documented to date; use of product parallels massive transfusion in the standard setting

Protocol Evolution

•  During the study period, total of 771 flights •  Only two pts received all 4 units of PRBC

during transport •  Product Order and Ratio

•  2009: 2 PRBC, 2 Plasma, 2 PRBC •  2010: 2 Plasma, 2 PRBC, 2 PRBC •  2011: 3 Plasma, 3 PRBC

Hemostatic Resuscitation in Our Trauma Center

•  Pre-hospital plasma and POC testing •  INR/Lactate pre-hospital

•  Early Diagnosis in ED – StO2/i-Stat •  1:1 ratio (thawed plasma to RBC)

•  Plasma-first transfusion sequence •  ED use of PCC?

•  Frequent TEG and early platelet use •  Minimal crystalloid •  Repeated doses of PCC and/or transfusion

in OR and ICU as required by TEG •  Young red cells (<14 days)

Ratios / Plasma Balance PTP (n=9) Control (n=50) p

En Route P:RBC 1.3 : 1.0 N/A <0.001 30 min P:RBC 1.3 : 1.0 0.14 : 1.0 <0.001 6 hr P:RBC 1.0 : 1.0 0.42 : 1.0 <0.001 24 hr P:RBC 1.0 : 1.0 0.45 : 1.0 <0.001 En Route Plasma Deficit - 0.4 - 1.0 0.32 30 min Plasma Deficit - 1.2 - 2.0 0.37 6 hr Plasma Deficit - 1.7 - 5.3 0.06 24 hr Plasma Deficit - 1.0 - 5.7 0.04

Time & the ‘Geographic Plasma

Deficit’

PTP (n=9) Control (n=50) p Facility Transfer 100% 54% 0.002 Transport à Trauma Ctr (min) 40 39 0.78 Injury à First Plasma (min) 194 231 0.58 Trauma Ctr arrivalàPlasma (min) - 34 97 0.013

•  ABO-identical preferred •  Universal plasma donor

•  Group AB •  Lacks anti-A/anti-B •  Pan-ABO compatible •  Rarest blood group

Group A Plasma Transfusion Introduction

Inaba K et al. Arch Surg 2010

Group A Plasma Transfusion Group AB supply

•  Recent safety data •  ABO incompatible platelets

•  1 – 2 plasma units

•  1 in 9000 hemolysis

•  Group O

•  Immunosuppression

Isaak EJ et al. Immunohematology 2011 Josephson CD et al. Transfus Apher Sci 2010

•  10,206 patients over study period •  Trauma patient •  July 2008 – June 2012 •  ≥ 1 unit emergency release plasma (group A

plasma) •  258 emergency release plasma (2.5%)

•  4 died prior to blood grouping

Group A Plasma Transfusion Results

•  254 patients •  35 ABO Incompatible (14%)

•  25 group B •  10 group AB

•  219 ABO Compatible (86%) •  116 group A •  103 group O

Group A Plasma Transfusion Results

Feature ABO Incompatible n = 35 ABO compatible

n = 219 P

Age (years) 56 (39-79) 59 (32-79) 0.944 Male sex 63% 63% 0.973 ISS 25 (16-37) 22 (12-30) 0.199 TRISS 0.86 (0.26-0.97) 0.93 (0.34-0.97) 0.880 Scene transfer 34% 38% 0.710 Time from injury to trauma

bay admission (mins) 145 (54-185) 172 (92-230) 0.214 Time in trauma bay (mins) 24 (20-35) 26.5 (20-36) 0.883 Time at referring hospital 119 (96-144) 121 (70-172) 0.920

Group A Plasma Transfusion Results

Group A Plasma Transfusion Results

ABO Incompatible n = 35 ABO compatible

N = 219 P

Ventilator days 6 (2-12) 3 (2-8) 0.070 ICU LOS (days) 4 (1-11) 3 (1-7) 0.155 Hospital LOS (days) 9 (3-24) 7 (3-17) 0.146 Complications 43% 35% 0.449

ALI 3.7% 2.5% 0.542 Possible TRALI 2.9% 3.0% 0.362

ARDS 2.9% 1.8% 0.527 Pneumonia 17% 9% 0.144

DVT 2.9% 4.1% 1.00 PE 5.8% 7.3% 1.00

Acute renal failure 0% 1.8% 0.420 Sepsis 0% 0.5% 0.689

Mortality 20% 22% 0.798

Group A Plasma Transfusion Results

ABO Incompatible n = 35

ABO compatible N = 219

P

Ventilator days 6 (2-12) 3 (2-8) 0.070 ICU LOS (days) 4 (1-11) 3 (1-7) 0.155 Hospital LOS (days) 9 (3-24) 7 (3-17) 0.146 Complications 43% 35% 0.449

ALI 3.7% 2.5% 0.542 Possible TRALI 2.9% 3.0% 0.362

ARDS 2.9% 1.8% 0.527 Pneumonia 17% 9% 0.144

DVT 2.9% 4.1% 1.00 PE 5.8% 7.3% 1.00

Acute renal failure 0% 1.8% 0.420 Sepsis 0% 0.5% 0.689

Mortality 20% 22% 0.798

Group A Plasma Transfusion Results

ABO Incompatible n = 35

ABO compatible N = 219 P

Ventilator days 6 (2-12) 3 (2-8) 0.070 ICU LOS (days) 4 (1-11) 3 (1-7) 0.155 Hospital LOS (days) 9 (3-24) 7 (3-17) 0.146 Complications 43% 35% 0.449

ALI 3.7% 2.5% 0.542 Possible TRALI 2.9% 3.0% 0.362

ARDS 2.9% 1.8% 0.527 Pneumonia 17% 9% 0.144

DVT 2.9% 4.1% 1.00 PE 5.8% 7.3% 1.00

Acute renal failure 0% 1.8% 0.420 Sepsis 0% 0.5% 0.689

Mortality 20% 22% 0.798

Product ABO Incompatible N = 35

ABO compatible N = 219

P Emergency release plasma

(units) 2 (1-4) 2 (1-4) 0.345 Total Incompatible Units 3 (2-4) 0 (0-0) <0.001 Total compatible units @ 24

hours 2 (0-6) 3 (2-6) 0.439 Total plasma @ 24 hours

(units) 6 (3-10) 4 (2-7) 0.444 Total RBC @ 24 hours (units) 5 (0-12) 4 (0-8) 0.472 Plasma:RBC @ 24 hours 1.3:1 1.1:1 0.155 Plasma deficit @ 24 hours 2 (0-3) 1 (-1-3) 0.195 Total Platelet units @ 24

hours 0 (0-2) 0 (0-1) 0.801

Group A Plasma Transfusion Results

Product ABO Incompatible N = 35

ABO compatible N = 219

P Emergency release plasma

(units) 2 (1-4) 2 (1-4) 0.345 Total Incompatible Units 3 (2-4) 0 (0-0) <0.001 Total compatible units @ 24

hours 2 (0-6) 3 (2-6) 0.439 Total plasma @ 24 hours

(units) 6 (3-10) 4 (2-7) 0.444 Total RBC @ 24 hours (units) 5 (0-12) 4 (0-8) 0.472 Plasma:RBC @ 24 hours 1.3:1 1.1:1 0.155 Plasma deficit @ 24 hours 2 (0-3) 1 (-1-3) 0.195 Total Platelet units @ 24

hours 0 (0-2) 0 (0-1) 0.801

Group A Plasma Transfusion Results

Product ABO Incompatible N = 35

ABO compatible N = 219

P Emergency release plasma

(units) 2 (1-4) 2 (1-4) 0.345 Total Incompatible Units 3 (2-4) 0 (0-0) <0.001 Total compatible units @ 24

hours 2 (0-6) 3 (2-6) 0.439 Total plasma @ 24 hours

(units) 6 (3-10) 4 (2-7) 0.444 Total RBC @ 24 hours (units) 5 (0-12) 4 (0-8) 0.472 Plasma:RBC @ 24 hours 1.3:1 1.1:1 0.155 Plasma deficit @ 24 hours 2 (0-3) 1 (-1-3) 0.195 Total Platelet units @ 24

hours 0 (0-2) 0 (0-1) 0.801

Group A Plasma Transfusion Results

Group A Plasma Transfusion Discussion

•  Emergency plasma use is increasing

•  Limited access

•  “New” universal

donor resulted in 97.6% reduction in AB plasma use

Group A Plasma Transfusion Discussion

•  Group A plasma has equivalent outcomes to group AB •  Incompatible transfusions occurred •  No hemolytic reactions •  Similar mortality •  Similar immunogenic complications

•  Limitations

•  Small comparison group

•  Type II error potential

•  Post-hoc analysis

43

CRASH-2 Study Lancet, Online Article, 2010

•  Prospective, randomized controlled trial •  20,211 patients •  TXA significantly reduced all cause mortality from 16.0% to

14.5% •  TXA significantly reduced death due to bleeding from 5.7% to

4.9% 43

44

45

StO2

Beilman Study •  Over a 15-month period, seven Level I trauma centers in

the USA enrolled 383 patients, 50 of whom developed MODS

•  StO2 below 75% indicates serious hypoperfusion in trauma patients

•  78% of patients who developed MODS, and 91% of patients who died, had StO2 below 75% in the first hour

•  Trauma patients who maintained StO2 above 75% within the first hour had an 88% chance of MODS-free survival

J Trauma 2006

Can early StO2 predict the need of blood product requirement in trauma

population?

Total 632 level 1 trauma 325 patients with recorded StO2

Variable  StO2< 65

n=23  StO2>65

n=302  p  

Systolic blood pressure, (SD) NS Heart rate, (SD) NS

Scene Assessment

Variable  StO2< 65

n=23  StO2>65

n=302  p  

Systolic blood pressure, (SD) 0.23 Heart rate, (SD) 0.39 Respiratory rate, (SD) 0.06 O2 saturation, (SD) 0.2

Temperature, (SD) 36.1 (1.2) 36.6 (0.7) Trauma score, (SD) 9 (2) 10 (2) Glasgow coma score, (SD) 7.7 (6) 10 (6)

Emergency Department Assessment

Variable StO2< 65

n=23

StO2>65 n=302

p

Hemoglobin, (SD) NS Hematocrit, (SD) NS pH, (SD) NS Base deficit, (SD) NS Lactate, (SD) 3.9 (3.2) 2.4 (2.1) FAST done NS Positive FAST NS

Laboratory Results and FAST

Variable StO2< 65

N=23

StO2>65 N=302

p

ICU  days,  (SD)   NS  Hospital  length  of  stay,  (SD)   NS  Mortality     NS  

Surgical  interven.on   18  (78%)   152  (50%)  Morbidity   11  (48%)   68  (23%)  

Outcomes

Multivariate analysis

Variable p

StO2  <  65%   0.01  Systolic  BP   0.11  Heart  rate   0.97  O2  satura.on   0.91  Lactate  level   0.25  Age   0.32  ISS   0.33  GCS   0.74  Posi.ve  FAST   0.19  

Current Status •  All 3 Mayo helicopter bases carrying 3 PRBC

and 3 thawed plasma •  All 3 use same transfusion triggers •  All 3 use i-Stat INR and ABG cartridges •  All 3 carry TXA; uses similar triggers but has

some limitations for use •  Just added StO2 as a trigger •  Limited waste at all 3 sites •  No crystalloid for those with hemorrhage •  Tourniquets and Combat Gauze on all 3 ships

The Future •  Freeze dried plasma? •  Whole blood? •  Platelets? •  Prothrombin complex concentrates?

Why Freeze Dried Plasma?

Remote Damage Control Resuscitation!

Implementation of Change •  Consensus •  Review of the literature and our own data •  Practicality and safety are first order of

business with best interest of patient in mind •  Continuous monitoring of program •  Education of all health care providers •  Willingness of blood bank and transfusion

medicine to consider novel use of products

Overall System Results •  Current era (2011) compared to the era

before pre-hospital plasma •  Referrals up (838 vs 998*) •  ISS up (9 vs 12*) •  Mortality same (2.5% vs 2.2%) •  Observed decline open abdomen (under study) •  Observed decline in massive tx (under study) •  Arrival TEG improved? (under study)

Summary •  Trauma patients die from shock •  Our job is to limit preventable trauma death •  First, identify the patient in shock •  Pre-hospital resuscitation with plasma can

prevent the trauma induced coagulopathy and limit the risk of death due to hemorrhage

•  Making dried plasma available in the rural and pre-hospital/austere environment will save lives

Thank You!

Questions?