Status:
RECRUITING
Evaluation of a Transfusion Therapy Using Whole Blood in the Management of Coagulopathy in Patients with Acute Traumatic Hemorrhage
Lead Sponsor:
Direction Centrale du Service de Santé des Armées
Collaborating Sponsors:
TIMC-IMAG
Floralis
Conditions:
Trauma
Acute Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The prognosis of traumatized hemorrhages is correlated with the nature of transfusion therapy: a 50% reduction in mortality for an early and massive supply of plasma, and 20% for an early and massive ...
Detailed Description
In recent years, terrorist attacks have confronted the investigator's healthcare system with a massive influx of victims of war weapon injuries. This new fact makes the efficiency of transfusion thera...
Eligibility Criteria
Inclusion
- Severe trauma patients requiring the initiation of a massive transfusion protocol determined on
- 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
- 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
- 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
- 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...)
Key Trial Info
Start Date :
December 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04431999
Start Date
December 4 2021
End Date
January 1 2026
Last Update
February 17 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU de La Cavale Blanche - Brest
Brest, France, 29200
2
HIA Percy
Clamart, France, 92140
3
CHU de Grenoble
Grenoble, France, 38000
4
CHU de La Pitié-Salpêtrière
Paris, France, 75013