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Pre-hospital RBC, Fibrinogen, and TXA for Severe Trauma Hemorrhage
NCT04149171Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2018
- Primary completion
- Dec 2020
- Countries
- 1
- Modality
- Recombinant Proteins and Enzymes, Cell Therapies
- Conditions
- hemorrhagic shocktrauma-induced coagulopathy (TIC)
01
Overview
Phase 3, open-label trial of Fibrinogen human and red blood cells in hemorrhagic shock and trauma-induced coagulopathy (TIC) (2 arms). Primary endpoint: Percentage of red blood cells returned to Blood and Tissue bank compared to red blood cells delivered at 72 hours. Started Sep 2018; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Experimental: RBC + TXA + Fibrinogen
Red blood cells, Tranexamic acid, and Fibrinogen Concentrate
Control: Crystalloids + TXA
Standard treatment with Crystalloids and Tranexamic acid
03
Who it enrols
Adult patients with severe trauma and evidence of bleeding or high risk of transfusion, excluding those with pre-existing coagulopathies, anticoagulant use, or severe isolated TBI.
04
Endpoints
Primary
Percentage of red blood cells returned to Blood and Tissue bank compared to red blood cells delivered
Secondary
Mortality
Transfusion requirements
Crystalloid administration
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