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

NCT04149171 | Completed Phase 3

• 1 other identifier: EudraCT number 2018-001867-22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Hemorrhagic Shock

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

conventional treatment

EXPERIMENTAL

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

Drug: conventional treatment

conventional treatment added to Crystalloids and TXA

ACTIVE COMPARATOR

administration of Crystalloids and TXA

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

Interventions

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

Also known as: red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate

conventional treatment added to Crystalloids and TXA

conventional treatment DRUG

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

conventional treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cristina Martinez: lead

Study Sites (1)

Hospital Dr Josep Trueta

Girona, 17007, Spain

Location

MeSH Terms

Conditions

Shock, Hemorrhagic

Interventions

Erythrocyte Count; Tranexamic Acid

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Jordi Vila, MD

  Hospital Dr Josep Trueta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master of science, Study Coordinator

Model Details: This is a single-center, not-randomized, open-label, controlled pilot clinical trial. This study compares presence of 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.

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: November 4, 2019
• Study Start: September 26, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2022
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)