Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients

Study Overview
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Brief Summary
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Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion. Objectives Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome) Evaluate total transfusion in each group in the first 24 hours (Secondary Outcome) including breakdown by FFP equivalents, platelet units, and cryoprecipitate Evaluate 6 hour, 24 hour, and hospital mortality (Secondary Outcome) Evaluate ICU outcomes in each group

Detailed Description
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Based on the results from Cotton et al, median transfusion in the component therapy group was 6 PRBC in the first 24 hours and 4 PRBC equivalents in the whole blood group. The standard deviation (estimated from the interquartile range) was approximately 4. Thus with an expectation of alpha = 0.05 and expected power of 90% to detect a similar 2 unit difference in transfusion volume, a sample size of 190 should be sufficient; thus projected sample size of 200 should be more than adequate. Age range will be 18 years and older, and only males will be included in the study. Expected racial/ethnic distribution will be approximately 60% white, 15% black, 8% Asian, and 18% other race. No actual recruitment will be performed; rather all qualifying patients will be included. Consent waiver is being requested. b. Objectives Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome) Evaluate total transfusion in each group in the first 24 hours (Secondary Outcome) including breakdown by FFP equivalents, platelet units, and cryoprecipitate Evaluate 6 hour, 24 hour, and hospital mortality (Secondary Outcome) Evaluate ICU outcomes in each group: 1. ICU length of stay 2. Ventilator days 3. SOFA score on day of ICU discharge 4. Presence of ARDS 5. Presence of TRALI 6. Presence of DVT/PE 7. Necessity for Dialysis 8. Necessity for Tracheostomy 9. Evaluate viscoelastic testing parameters in both groups when sent on arrival in ICU 1. Percentage of patients with EXTEM clotting time > 80 sec 2. Percentage of patients with EXTEM amplitude at 10 min < 40mm and FIBTEM amplitude at 10 min ≤ 10mm 3. Percentage of patients with EXTEM amplitude at 10 min < 40mm and FIBTEM amplitude at 10 min > 10mm 4. Percentage of patients with maximum thrombolysis > 15% 5. Interval analyses to be performed after 6 and 12 months with provision to continue the study out to 24 months. 1. Stopping rule: A statistically significant difference in hospital mortality at 6 months or 12 months If in favor of LTOWB, consideration of trial termination and making LTOWB the primary standard of care for all trauma patients receiving emergency transfusion except for child-bearing age females (unless Rh immunoglobulin can be administered) If in favor of component therapy, consideration of trial termination and making component therapy the primary standard care for all trauma patients receiving emergency transfusion

Official Title
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Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients

Conditions
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Hemorrhagic Shock, Acute Blood Loss Anemia, Traumatic Brain Injury

Intervention / Treatment
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* Combination Product: Routine labs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all adult male patients brought into the emergency department as LEVEL A trauma activations who are receiving emergency blood transfusions Exclusion Criteria: Female patients (specifically excluded due to risk of alloimmunization of Rh-negative female patients of childbearing age against Rh-positive blood) children prisoners all patients classified as dead upon arrival to the trauma bay

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Titer O+ Whole Blood<br>Low Titer O+ Whole blood provided to Level A trauma patients | Combination Product: Routine labs<br>* Routine labs will be performed with CBC, BMP, Fox screen, ROTEM viscoelastic test, PT/INR, PTT and venous lactate for standard of care for all patients.<br>|
| Active Comparator: Component Therapy<br>Component Therapy of O+ pRBC and FFP dispatched to trauma bay for level A traumas | Combination Product: Routine labs<br>* Routine labs will be performed with CBC, BMP, Fox screen, ROTEM viscoelastic test, PT/INR, PTT and venous lactate for standard of care for all patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pRBC equivalents transfused | assessment of pRBC equivalents transfused in each arm, an increase in HGB by 1g/dl per unit transfused will be considered successful A blood draw of 5ml will be obtained and tested to assess HGB level. An increase in HGB by 1g/dl per unit transfused will be considered a successful result. | 24 hours post ED admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Assessment of mortality This is a composite measurement which includes the following in order to be assessed as pulseless with no respiratory drive or brain death: there is no evidence of arousal or awareness to maximal external stimuli pupils are fixed in a midsized or dilated position and non reactive to light corneal, oculocephalic and oculovestibular reflexes are absent There is no facial movement to noxious stimuli the gag reflex is absent to bilateral posterior pharyngeal stimuli the cough reflex is absent to deep tracheal suctioning there is no brain mediated motor response to noxious stimuli of the limbs spontaneous respirations are not observed when apnea test targets reach pH <7.30 and PaCO2 >60mmhg | Change between ED admission date and 24 hours post discharge |