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

PHASE3CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 26, 2018

Primary Completion Date

December 31, 2020

Study Completion Date

December 31, 2022

Conditions
Hemorrhagic Shock
Interventions
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.

DRUG

conventional treatment

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

Trial Locations (1)

17007

Hospital Dr Josep Trueta, Girona

All Listed Sponsors
lead

Cristina Martinez

OTHER

NCT04149171 - Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage | Biotech Hunter | Biotech Hunter