Evaluation of a Transfusion Therapy Using Whole Blood in the Management of Coagulopathy in Patients with Acute Traumatic Hemorrhage

Launched by DIRECTION CENTRALE DU SERVICE DE SANTÉ DES ARMÉES · Jun 12, 2020

Keywords

ClinConnect Summary

This clinical trial, called T-STORHM, is studying the use of whole blood transfusions to help patients who have experienced severe trauma and are bleeding heavily. The goal is to see if using whole blood is just as effective as traditional methods that separate blood into its components, like plasma and platelets. By using whole blood, it may be easier and quicker to provide the necessary treatment, especially in emergency situations where time is critical.

To be eligible for this trial, participants must be adults with serious injuries that require immediate and extensive blood transfusions. Key criteria include showing signs of severe blood loss or trauma, such as low blood pressure or the need for urgent medical procedures. Participants can expect to receive careful monitoring and treatment as part of the study, helping researchers understand how whole blood transfusions can impact recovery in traumatic situations. Importantly, this trial is currently recruiting participants and aims to improve emergency care for patients facing life-threatening injuries.

Gender

ALL

Eligibility 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...)