Status:
COMPLETED
Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care.
Lead Sponsor:
Banc de Sang i Teixits
Conditions:
Polytrauma
Traumatic Hemorrhage
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
PHASE2
Brief 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-...
Detailed Description
A pilot, non-randomized, open-label study of two intervention arms and controlled with the standard treatment in which 60 patients affected with acute hemorrhage due to severe trauma will enter the st...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2022
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT03780894
Start Date
November 21 2018
End Date
January 11 2022
Last Update
January 25 2024
Active Locations (1)
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1
Hospital Josep Trueta
Girona, Spain, 17007