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

Hemorrhagic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04149171
• Other study ID #: EudraCT number 2018-001867-22
• Status: Completed
• Phase: Phase 3
• Start date: September 26, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2023
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Hemorrhagic Shock
• Shock, Hemorrhagic

Intervention

Drug:
• 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.
• conventional treatment
standard treatment based on crystalloid fluid and tranexamic acid (TXA)

Locations

Country	Name	City	State
Spain	Hospital Dr Josep Trueta	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Cristina Martinez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of red blood cells returned to Blood and Tissue bank located in Josep Trueta hospital compared to red blood cells delivered at medical emergency system (SEM) units H2, G500 and G409.	number of transfusions used during 72 hours	72 hours