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Whole blood may be just as good as standard transfusions for trauma bleeding

NCT ID NCT04431999

Disease control Sponsor: Direction Centrale du Service de Santé des Armées Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving whole blood (all blood parts together) works as well as giving separate blood parts (red cells, plasma, platelets) to people with severe bleeding from trauma. About 200 patients who needed a massive transfusion were included. The goal was to see if whole blood corrects bleeding problems just as well, which could simplify emergency care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

200 people

The number who actually took part.

Started

Dec 2021

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Severe trauma patients requiring the initiation of a massive transfusion protocol determined on 1. At least two Red flag score factors (according to pre-hospital data) : * Suspected pelvic fracture * Shock index (FC / PAS)\> = 1 * Microdose hemoglobin \<13g * Average blood pressure \<70 mmHg * Need for prehospital tracheal intubation 2. AND at least two criteria of the Assessment of Blood Consumption (ABC) score established at the patient's arrival: * Penetrating trauma * Focused Abdominal Sonography for Trauma (FAST) echo positive * Blood pressure \<90 mmHg * Respiratory rate \>120 bpm 3. AND/OR after clinical assessment and on the prediction of the practitioner in charge of the treatment of the injured person of the need to transfuse during the emergency management of the injured person Exclusion Criteria: * Non-traumatic hemorrhage * Patients transfused with more than two PRBCs before the initiation of the massive transfusion protocol. * Anti-coagulation treatment * Pregnancy * Age \< 18 years * Patient refusing administration of blood products * Patient transferred from another hospital * Patient nor transported by a physician-staffed prehospital emergency medical system * Burn patient (≥30% of body surface). * Patient under specific known transfusion protocol (for example : allo immunization...)

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Conditions

The condition(s) this trial relates to.

blood coagulation disease injury vascular hemostatic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute hemorrhage Coagulopathy Trauma

Contacts and locations

Locations

  • CHU de Grenoble

    Grenoble, 38000, France

  • CHU de La Cavale Blanche - Brest

    Brest, 29200, France

  • CHU de La Pitié-Salpêtrière

    Paris, 75013, France

  • CHU du Kremlin Bicêtre

    Paris, 94270, France

  • HIA Percy

    Clamart, 92140, France

  • HIA Sainte Anne

    Toulon, 83000, France

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