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

Loma Linda University (LLU)

Status and phase: Completed; Phase 3

Conditions: Traumatic Brain Injury; Hemorrhagic Shock; Acute Blood Loss Anemia

Treatments: Combination Product: Routine labs

Study type: Interventional

Funder types: Other

Identifiers

NCT05081063

5210170

Details and patient eligibility

About

Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion.

Objectives

1. Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome)
2. Evaluate total transfusion in each group in the first 24 hours (Secondary Outcome) including breakdown by FFP equivalents, platelet units, and cryoprecipitate
3. Evaluate 6 hour, 24 hour, and hospital mortality (Secondary Outcome)
4. Evaluate ICU outcomes in each group

Full description

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

1. Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome)

2. Evaluate total transfusion in each group in the first 24 hours (Secondary Outcome) including breakdown by FFP equivalents, platelet units, and cryoprecipitate

3. Evaluate 6 hour, 24 hour, and hospital mortality (Secondary Outcome)

4. Evaluate ICU outcomes in each group:

5. 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

6. 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.

7. Stopping rule: A statistically significant difference in hospital mortality at 6 months or 12 months

8. 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)

9. 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

Enrollment: 201 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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201 participants in 2 patient groups

Low Titer O+ Whole Blood

Experimental group

Description:

Low Titer O+ Whole blood provided to Level A trauma patients

Treatment:

Combination Product: Routine labs

Component Therapy

Active Comparator group

Description:

Component Therapy of O+ pRBC and FFP dispatched to trauma bay for level A traumas

Treatment:

Combination Product: Routine labs