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

NCT04149171 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-10-06

No results posted yet for this study

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)

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)

Sponsors & Collaborators

  • Cristina Martinez

    lead OTHER

Principal Investigators

  • Jordi Vila, MD · Hospital Dr Josep Trueta

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-26
Primary Completion
2020-12-31
Completion
2022-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04149171 on ClinicalTrials.gov