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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Banc de Sang i Teixits
• Collaborators: IDIBGI (Institut d'Investigació Biomèdica de Girona Dr. Trueta); Sistema d'Emergències Mèdiques (SEM)
• Treatments: Tranexamic Acid

Criteria

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