Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage
Condition: Hemorrhagic Shock
MeSH terms: Hemorrhage; Shock, Hemorrhagic
Study type: Interventional
Phase: Phase 3

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)
    

Detailed 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
    

Intervention name(s): with red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC),administration of Crystalloids and TXA.; conventional treatment
Intervention type(s): Drug; Drug
Intervention description(s): The treating physician must have evaluated the patient's eligibility and approved the patient's enrolment in the trial prior to blood samples extraction and RBC, TXA and Fibrinogen Concentrate administration. The experimental and control arms will be determined according to the medical emergency system units with RBC, TXA and Fibrinogen Concentrate administration capacity which will be the H2 helicopter unit ,fast intervention vehicle and G409 ambulance (Advanced Life Support). The medical emergency system units are activated according current protocols based on distance, severity and weather conditions.; standard treatment based on crystalloid fluid and tranexamic acid (TXA)
Other intervention name(s): red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate
Intervention MeSH terms: Tranexamic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a single-center, not-randomized, open-label, controlled pilot clinical trial. This study compares presence of 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.
Masking: None (Open Label)
Primary purpose: Prevention