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NCT05081063 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Loma Linda University.

Completed
Registry status
Phase 3
Development phase
199
Enrollment target

NCT05081063: Completed Phase 3 study, sponsored by Loma Linda University.

NCT05081063 is a Phase 3 study that has completed, run by Loma Linda University. The registered enrollment target is 199 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05081063, a Phase 3 study, has completed, sponsored by Loma Linda University.

COMPLETED
Registry status
Phase 3
Development phase
199 participants
Enrollment target

Study 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

Primary Outcome

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.

Interventions

  • COMBINATION_PRODUCT Routine labs

Trial Details

FieldValue
Enrollment Target 199 participants
Start Date 2022-03-05
Est. Completion 2023-05-15
Phase Phase 3
Loma Linda University

237 total trials

What the finished NCT05081063 record still lists

NCT05081063 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 1 intervention - of which Routine labs is the first listed.

NCT05081063 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05081063 about?

NCT05081063 is a clinical study titled "Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients". 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 ...

What is the current status of trial NCT05081063?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 199 participants. The study started on 2022-03-05. Estimated completion is 2023-05-15.

What interventions are being tested in trial NCT05081063?

The interventions under investigation include: Routine labs (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT05081063?

This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05081063's enrollment target sits among peer trials

199 1388th of 2000 higher than 612 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05081063, the US trial registry maintained by the National Library of Medicine. NCT05081063 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.