Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Study Design: Single-center, not-randomized, open-label, two-arms controlled pilot clinical trial.

Health Condition: Patients with severe trauma with a need for transfusion and categorized as priority 0 or 1 according to the Catalan Health Service (CatSalut) Polytrauma Code (PPT)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cristina Martinez
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Age ≥18 years AND

• Patients with severe trauma categorized as priority 0 or 1 according to the Catalan Health Service (CatSalut). Polytrauma Code (PPT) AND

• Evidence of bleeding or a high bleeding suspicion according to physician judgment OR o Predicted to need transfusion according to TICS (Yale Global Tics Severity Scale) 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.