Trial | NCT03780894  Report issue

Title

Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care.
Transfusion of Red Blood Cells (RBC), Tranexamic Acid (TXA) and Fibrinogen Concentrate (FC) for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. A Pilot Trial.

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    60
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.
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.
Study Started
Nov 21
2018
Primary Completion
Jan 11
2021
Study Completion
Oct 30
2023
Anticipated
Last Update
Jul 17
2023

Drug Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]

Administration of 2 mg of FC together with RBC and TXA

Biological Red blood cells concentrate

Administration of 2 red blood cells concentrates together with FC and TXA

Drug Tranexamic Acid

Administration of 1g of TXA together with FC and RBC

Experimental treatment Experimental

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 Active Comparator

Patients in the control arm will be treated according the existing protocols based on crystalloids and tranexamic acid administration.

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
No Results Posted