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

NCT05081063 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2025-08-08

Study results available
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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

Conditions

Interventions

COMBINATION_PRODUCT

Routine labs

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.

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-05
Primary Completion
2023-05-15
Completion
2023-05-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05081063 on ClinicalTrials.gov