CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 199 enrolled
Drug / intervention
Routine labscombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT05081063
NCT05081063Phase 3Completed
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Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients

Loma Linda University·interventional·Posted Oct 18, 2021·Updated Aug 8, 2025

In Brief

A Phase 3 clinical trial evaluating Routine labs for Hemorrhagic Shock and 2 related conditions. Completed, enrolled 199 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhagic Shock, Acute Blood Loss Anemia, Traumatic Brain Injury
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedOct 18, 2021
Enrollment StartMar 5, 2022
Primary CompletionMay 15, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.7 years ago

Interventions

Routine labscombination

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.