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

NCT03780894 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2024-01-25

No results posted yet for this study

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

Interventions

DRUG

Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]

Administration of 2 mg of FC together with RBC and TXA

BIOLOGICAL

Red blood cells concentrate

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

DRUG

Tranexamic Acid

Administration of 1g of TXA together with FC and RBC

Sponsors & Collaborators

  • Banc de Sang i Teixits

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-11-21
Primary Completion
2021-01-11
Completion
2022-01-11

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 NCT03780894 on ClinicalTrials.gov