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

Phase 3

Completed

• Conditions: Traumatic Brain Injury; Hemorrhagic Shock; Acute Blood Loss Anemia
• Interventions: Combination Product: Routine labs

• Registration Number: NCT05081063
• Lead Sponsor: Loma Linda University

Brief Summary

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

Detailed 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:

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

1. 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)

2. 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

Study Timeline

• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-18
• Study Start: 2022-03-05
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Component Therapy	Routine labs	Component Therapy of O+ pRBC and FFP dispatched to trauma bay for level A traumas
Low Titer O+ Whole Blood	Routine labs	Low Titer O+ Whole blood provided to Level A trauma patients

Primary Outcome Measures

Name	Time	Method
pRBC equivalents transfused	24 hours post ED admission	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.

Secondary Outcome Measures

Name	Time	Method
Mortality	Change between ED admission date and 24 hours post discharge	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: 1. there is no evidence of arousal or awareness to maximal external stimuli; 2. pupils are fixed in a midsized or dilated position and non reactive to light; 3. corneal, oculocephalic and oculovestibular reflexes are absent; 4. There is no facial movement to noxious stimuli; 5. the gag reflex is absent to bilateral posterior pharyngeal stimuli; 6. the cough reflex is absent to deep tracheal suctioning; 7. there is no brain mediated motor response to noxious stimuli of the limbs; 8. spontaneous respirations are not observed when apnea test targets reach pH \<7.30 and PaCO2 \>60mmhg

Trial Locations

Locations (1)

Loma Linda University Health; 🇺🇸 Loma Linda, California, United States