Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care.
- Conditions
- PolytraumaTraumatic Hemorrhage
- Interventions
- Biological: Red blood cells concentrate
- Registration Number
- NCT03780894
- Lead Sponsor
- Banc de Sang i Teixits
- 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-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.
- 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 study with the main objective of evaluating the feasibility and the efficacy of early treatment during the pre-hospital care phase with packed red blood cells, fibrinogen concentrate and tranexamic acid (experimental arm) compared to the standard treatment based on crystalloids administration and tranexamic acid (control arm). The secondary objectives are to evaluate the safety and clinical evolution of the patients. Prior to the administration of the treatment, 2 blood samples will be extracted in both groups in order to compare the coagulation status and to be able to perform the pre-transfusion tests. On arrival at the hospital, another sample will be taken to compare changes in coagulation after the administration of the experimental or standard treatment and also between both groups. The assessment of the coagulation status will be made using the values provided by the viscoelastic test (TEG6s). The experimental and standard treatment will be administered endovenously. After treatment, patients will be evaluated up to 30 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental treatment Fibrinogen Concentrate (Human) 1 MG [RiaSTAP] The active treatment consists of intravenous injection of 2g of fibrinogen concentrate, 1g of tranexamic acid, 2 red bood cells concentrate O Rh(D) negative (Banc de Sang i Teixits, Barcelona, Spain), and crystalloids at pre-hospital phase of care. Experimental treatment Red blood cells concentrate The active treatment consists of intravenous injection of 2g of fibrinogen concentrate, 1g of tranexamic acid, 2 red bood cells concentrate O Rh(D) negative (Banc de Sang i Teixits, Barcelona, Spain), and crystalloids at pre-hospital phase of care. Experimental treatment Tranexamic Acid The active treatment consists of intravenous injection of 2g of fibrinogen concentrate, 1g of tranexamic acid, 2 red bood cells concentrate O Rh(D) negative (Banc de Sang i Teixits, Barcelona, Spain), and crystalloids at pre-hospital phase of care. Standard treatment Tranexamic Acid Patients in the control arm will be treated according the existing protocols based on crystalloids and tranexamic acid administration.
- Primary Outcome Measures
Name Time Method All-cause mortality 24 hours post hospital admission Mortality for any cause
Temperature storage conditions of the red blood cells concentrate 24 hours Red bood cells concentrate out of temperature range for storage
TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC) Basal (at the hospital arrival) TEG6s(R) parameters that define TIC
Accountability 30 days Red bood cells concentrate accountability
- Secondary Outcome Measures
Name Time Method Adverse Events 30 days post hospital admission (or previously at hospital discharge) Treatment emergent adverse events
Crystalloid fluid requirements 30 days post hospital admission (or previously at hospital discharge) Volume of crystalloids required
Ventilator-free days 30 days Ventilator-free days at the ICU
Thromboembolism events 30 days Thromboembolism events
Transfusion requirements 30 days post hospital admission (or previously at hospital discharge) Transfusion requirements of RBC, platelets and plasma
All-cause mortality 30 days post hospital admission Mortality for any cause
Water balance 72 hours of admission at the ICU Water balance at the Intensive Care Unit (ICU)
Trial Locations
- Locations (1)
Hospital Josep Trueta
🇪🇸Girona, Spain