Transfusion of Red Blood Cells (RBC), Tranexamic Acid (TXA) and Fibrinogen Concentrate (FC) for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. A Pilot Trial.

PRETIC

This is a single-center, not-randomized, open-label, controlled pilot clinical trial. This study compares presence of Trauma Induced Coagulopathy (TIC) and acute traumatic hemorrhage treatment at pre-hospital phase of care with red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC) with the current treatment based on the administration of Crystalloids and TXA.

2018-11-21

2021-01-11

2022-01-11

Completed

Early phase I

79

Inclusion Criteria: * Age ≥18 years AND * Patients with severe trauma categorized as priority 0 or 1 according to the CatSalut Polytrauma Code (PPT) AND * Evidence of bleeding or a high bleeding suspicion according to physician judgment OR * Predicted to need transfusion according to TICCS score ≥10 Exclusion Criteria: * Moribund patient with devastating injuries and expected to die within 1-hour OR * Known objection to blood components transfusion OR * Known acquired or congenital coagulopathies not related to the actual trauma OR * Known anticoagulant treatment (vitamin K antagonist, dabigatran, rivaroxaban, apixaban) OR * Known Pregnancy OR * Severe isolated traumatic brain injury OR * Hemorrhage not related to the actual trauma

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center, non-randomized, open-label, two-arms, controlled pilot clinical trial.\n\nThe experimental and control arms will be determined according to the SEM units with RBC, TXA and FC administration capacity (i.e. helicopter unit, rapid intervention ambulance or advanced life support ambulance). The emergency SEM units are activated according current protocols based on distance, severity and weather conditions.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 79, 'type': 'ACTUAL'}}

2024-01-25