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

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:

• 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

• 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.

• 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

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