Using whole blood to treat severe bleeding in trauma patients
Evaluation of a Transfusion Therapy Using Whole Blood Versus Fractionated Blood Products in the Management of Coagulopathy in Patients Admitted to Hospital for Acute Traumatic Hemorrhage
This study is testing if using whole blood for transfusions can help trauma patients with severe bleeding just as well as the usual method of using separate blood components.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Direction Centrale du Service de Santé des Armées Academic / other |
| Locations | 6 sites (Brest and 5 other locations) |
| Trial ID | NCT04431999 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of whole blood transfusion therapy compared to traditional component therapy (red blood cells, plasma, and platelets) in managing coagulopathy in patients suffering from acute traumatic hemorrhage. The study is designed as a randomized, controlled, parallel trial to determine if whole blood transfusions are non-inferior to standard treatments in emergency situations, particularly in the context of mass casualty incidents. The approach aims to simplify the transfusion process and improve the availability of necessary blood components during critical situations, such as terrorist attacks. The trial is particularly relevant given the increasing incidence of trauma from violent events.
Who should consider this trial
Good fit: Ideal candidates for this study are severe trauma patients who meet specific criteria indicating the need for massive transfusion protocols.
Not a fit: Patients with non-traumatic hemorrhage or those who have already received more than two units of red blood cells prior to the initiation of the massive transfusion protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality rates in trauma patients experiencing severe hemorrhage.
How similar studies have performed: Previous studies have shown promising results with the use of whole blood in military settings, suggesting potential for success in civilian trauma care.
Eligibility criteria
Show full inclusion / exclusion criteria
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...)
Where this trial is running
Brest and 5 other locations
- CHU de La Cavale Blanche - Brest — Brest, France (Recruiting)
- HIA Percy — Clamart, France (Recruiting)
- CHU de Grenoble — Grenoble, France (Recruiting)
- CHU de La Pitié-Salpêtrière — Paris, France (Recruiting)
- CHU du Kremlin Bicêtre — Paris, France (Recruiting)
- HIA Sainte Anne — Toulon, France (Recruiting)
Study contacts
- Principal investigator: Sylvain AUSSET — Institution Nationale des Invalides
- Study coordinator: Sylvain AUSSET
- Email: sylvain.ausset@invalides.fr
- Phone: +33 6 71 58 51 30
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.