Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage

NCT ID: NCT04149171

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-26
• Study Completion Date: 2022-12-31

Brief 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

Conditions

Hemorrhagic Shock

Study Design

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

Study Groups

conventional treatment

red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC)

Group Type: EXPERIMENTAL

conventional treatment

Intervention Type: DRUG

standard treatment based on crystalloid fluid and tranexamic acid (TXA)

conventional treatment added to Crystalloids and TXA

administration of Crystalloids and TXA

Group Type: ACTIVE_COMPARATOR

with red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC),administration of Crystalloids and TXA.

Intervention Type: DRUG

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.

Interventions

with red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC),administration of Crystalloids and TXA.

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.

Intervention Type: DRUG

conventional treatment

standard treatment based on crystalloid fluid and tranexamic acid (TXA)

Intervention Type: DRUG

Other Intervention Names

red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years AND
• Patients with severe trauma categorized as priority 0 or 1 according to the Catalan Health Service (CatSalut). Polytrauma Code (PPT) AND
• Evidence of bleeding or a high bleeding suspicion according to physician judgment OR o Predicted to need transfusion according to TICS (Yale Global Tics Severity Scale) 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: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cristina Martinez

OTHER

Sponsor Role: lead

Responsible Party

Cristina Martinez

Master of science, Study Coordinator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jordi Vila, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Dr Josep Trueta

Locations

Hospital Dr Josep Trueta

Girona, , Spain

Countries

Spain

Other Identifiers

EudraCT number 2018-001867-22

Identifier Type: -

Identifier Source: org_study_id