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

NCT03780894 | Completed Phase 1

• 1 other identifier: PRETIC
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, not-randomized, open-label, controlled pilot clinical trial. This study compares presence of Trauma Induced Coagulopathy (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.

Conditions

Polytrauma; Traumatic Hemorrhage

Keywords

Polytrauma; Red blood cells transfusion; Acute traumatic hemorrhage

Outcome Measures

Primary Outcomes (7)

• TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)

  TEG6s(R) parameters that define TIC

  Basal (at the crash site)

• TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)

  TEG6s(R) parameters that define TIC

  Basal (at the hospital arrival)

• All-cause mortality

  Mortality for any cause

  1 hour post hospital admission

• All-cause mortality

  Mortality for any cause

  6 hours post hospital admission

• All-cause mortality

  Mortality for any cause

  24 hours post hospital admission

• Accountability

  Red bood cells concentrate accountability

  30 days

• Temperature storage conditions of the red blood cells concentrate

  Red bood cells concentrate out of temperature range for storage

  24 hours

Secondary Outcomes (11)

• All-cause mortality

  48 hours post hospital admission

• All-cause mortality

  30 days post hospital admission

• Adverse Events

  30 days post hospital admission (or previously at hospital discharge)

• Thromboembolism events

  30 days

• Crystalloid fluid requirements

  1 hour (from the crash site to the hospital admission)

Study Arms (2)

Experimental treatment

EXPERIMENTAL

The active treatment consists of intravenous injection of 2g of fibrinogen concentrate, 1g of tranexamic acid, 2 red bood cells concentrate O Rh(D) negative (Banc de Sang i Teixits, Barcelona, Spain), and crystalloids at pre-hospital phase of care.

Drug: Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]; Biological: Red blood cells concentrate; Drug: Tranexamic Acid

Standard treatment

ACTIVE COMPARATOR

Patients in the control arm will be treated according the existing protocols based on crystalloids and tranexamic acid administration.

Drug: Tranexamic Acid

Interventions

Fibrinogen Concentrate (Human) 1 MG [RiaSTAP] DRUG

Administration of 2 mg of FC together with RBC and TXA

Experimental treatment

Red blood cells concentrate BIOLOGICAL

Administration of 2 red blood cells concentrates together with FC and TXA

Experimental treatment

Tranexamic Acid DRUG

Administration of 1g of TXA together with FC and RBC

Experimental treatment; Standard treatment

Eligibility Criteria

• Age: 18 Years - 90 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 CatSalut Polytrauma Code (PPT) AND
• Evidence of bleeding or a high bleeding suspicion according to physician judgment OR
• Predicted to need transfusion according to TICCS 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

• Banc de Sang i Teixits: lead

Study Sites (1)

Hospital Josep Trueta

Girona, 17007, Spain

Location

Related Links

• Blood and Tissue Bank of Catalonia
• HOspital Universitari Dr. Trueta (Girona, Spain)

MeSH Terms

Conditions

Multiple Trauma

Interventions

Fibrinogen; Tranexamic Acid

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, non-randomized, open-label, two-arms, controlled pilot clinical trial. The experimental and control arms will be determined according to the SEM units with RBC, TXA and FC administration capacity (i.e. helicopter unit, rapid intervention ambulance or advanced life support ambulance). The emergency SEM units are activated according current protocols based on distance, severity and weather conditions.

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 19, 2018
• Study Start: November 21, 2018
• Primary Completion: January 11, 2021
• Study Completion: January 11, 2022
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)