Phase 3 N=199 Randomized Single-blind Treatment

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

Hemorrhagic Shock · Acute Blood Loss Anemia · Traumatic Brain Injury

Bottom Line

View on ClinicalTrials.gov: NCT05081063 ↗

Enrolled (actual)

199

Serious AEs

0.0%

Results posted

Aug 2025

Primary outcome: Primary: Packed Red Blood Cells Equivalents Units Transfused (1 Whole Blood Unit Treated as 1 Packed Red Blood Cell Unit and 1 Fresh Frozen Plasma Unit) — 3.8; 5.7 units

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Routine labs (Combination_product)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Loma Linda University
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Packed Red Blood Cells Equivalents Units Transfused (1 Whole Blood Unit Treated as 1 Packed Red Blood Cell Unit and 1 Fresh Frozen Plasma Unit)	3.8; 5.7	—
SECONDARY Mortality	4; 13	—

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05081063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.