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

  • STATUS
    Recruiting
  • days left to enroll
    29
  • participants needed
    30
  • sponsor
    Cristina Martinez
Updated on 17 February 2022
crystalloid
conventional treatment
blood transfusion
tics
multiple injuries

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)

Description

Major hemorrhage in the setting of severe trauma patient is associated with significant morbidity and mortality. Hemorrhage is compounded by trauma induced coagulopathy of which hypo/dysfibrinogenemia and hypoperfusion play a significant role. There is a good evidence to suggest that hypofibrinogenemia in trauma is associated with worse outcomes and it is postulated that early replacement of fibrinogen and red blood cells packages may reduce hemorrhage and improve outcomes even in the pre-hospital phase of care. In this pilot study, the investigators will try to prove the feasibility and efficacy of managing the severe traumatic patient with red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate compared to standard treatment based on crystalloid fluid and TXA in the pre-hospital phase of care.

Early administration at pre-hospital phase of care of RBC, FC and TXA is feasible , secure and can help controlling trauma induced coagulopathy. Better outcomes in terms of mortality, less transfusion requirements and less crystalloid administration is expected

Details
Condition Hemorrhagic Shock
Treatment Conventional treatment, with red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC),administration of Crystalloids and TXA.
Clinical Study IdentifierNCT04149171
SponsorCristina Martinez
Last Modified on17 February 2022

Eligibility

Yes No Not Sure

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
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