NCT03780894

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.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Banc de Sang i Teixits · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polytrauma
• Traumatic Hemorrhage

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-11-21
• Primary completion: 2021-01-11
• Completion: 2022-01-11
• First posted: 2018-12-19
• Last updated: 2024-01-25

Locations

1 site across 1 country: Spain