Informations générales (source: ClinicalTrials.gov)
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 (T-STORHM)
Interventional
Phase 3
Direction Centrale du Service de Santé des Armées (Voir sur ClinicalTrials)
décembre 2021
janvier 2026
05 avril 2025
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 supply of platelets. However, this strategy encounters
logistical difficulties, particularly in a context of collective emergency (attacks). The
use of whole blood, widely documented by the Armed Forces, improves the availability of
plasma and platelets, and simplifies handling by the various actors in the chain.
T-STORHM is a randomized, controlled, parallel clinical trial.This study tests
non-inferiority of whole blood transfusion therapy in the management of coagulopathy in
patients with acute traumatic hemorrhage.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bicêtre | Marie WERNER | Contact (sur clinicalTrials) | |||
| HIA PERCY | Thibault MARTINEZ | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| HIA Sainte Anne - 83000 - Toulon - France | Eric Meaudre | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Grenoble - 38000 - Grenoble - France | Pierre BOUZAT | Contact (sur clinicalTrials) | |||
| CHU de La Cavale Blanche - Brest - 29200 - Brest - France | Philippe ARIES | Contact (sur clinicalTrials) | |||
| CHU de La Pitié-Salpêtrière - 75013 - Paris - France | Mathieu RAUX | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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
- 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...)