Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care.

NCT ID: NCT03780894

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-21
• Study Completion Date: 2022-01-11

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.

Conditions

Polytrauma; Traumatic Hemorrhage

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental treatment

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.

Group Type: EXPERIMENTAL

Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]

Intervention Type: DRUG

Administration of 2 mg of FC together with RBC and TXA

Red blood cells concentrate

Intervention Type: BIOLOGICAL

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

Tranexamic Acid

Intervention Type: DRUG

Administration of 1g of TXA together with FC and RBC

Standard treatment

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

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

Administration of 1g of TXA together with FC and RBC

Interventions

Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]

Administration of 2 mg of FC together with RBC and TXA

Intervention Type: DRUG

Red blood cells concentrate

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

Intervention Type: BIOLOGICAL

Tranexamic Acid

Administration of 1g of TXA together with FC and RBC

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Banc de Sang i Teixits

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Josep Trueta

Girona, , Spain

Countries

Spain

Related Links

http://www.bancsang.net

Blood and Tissue Bank of Catalonia

http://icsgirona.cat

HOspital Universitari Dr. Trueta (Girona, Spain)

Other Identifiers

PRETIC

Identifier Type: -

Identifier Source: org_study_id