drugset / Trial / NCT03780894

Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care.

NCT03780894

Phase 1/2 Completed 79 enrolled Blood and Tissue Bank of Catalonia
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2018-11-21
Primary completion
2021-01-11
Completion
2022-01-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Fibrinogen Concentrate Human Protein / enzyme biologic 2 g Intravenous
Subject Red blood cells concentrate Unknown 2 unknown Intravenous
Background Tranexamic Acid Small molecule 1 g Intravenous

Indications

No indication recorded.