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TRANexamic Acid to Reduce Bleeding in BURN Surgery

NCT03113253 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2024-04-04

No results posted yet for this study

Summary

Excision and grafting in burn patients can lead to severe blood loss. A preliminary study conducted in Saint Joseph Saint Luc Hospital showed that the total median blood loss was 1412 mL (1). Transfused patients had a total median blood loss of 2468 mL and an average number of 4 packed red blood cells (PRBC) administered.

Among the various methods that help limit blood loss, tranexamic acid, which has been proved useful in traumatology and surgery, has not been sufficiently studied in burn patients. A preliminary study in 27 burned patients showed a reduction of blood loss with tranexamic acid (2).

Objective of TRANBURN study is to demonstrate that tranexamic acid help limit blood loss and reduces the use of blood products.

Conditions

  • Tranexamic Acid
  • Burns
  • Surgery
  • Wounds and Injuries

Interventions

DRUG

Tranexamic Acid

DRUG

Placebo

0.9% sodium chloride to mimic tranexamic acid

Sponsors & Collaborators

  • Société Française d'Anesthésie et de Réanimation

    collaborator OTHER

  • Centre Hospitalier Saint Joseph Saint Luc de Lyon

    lead OTHER

Principal Investigators

  • Mathieu Fontaine, MD, PhD · Saint Joseph Saint Luc Hospital, Burn Intensive Care Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-22
Primary Completion
2021-11-02
Completion
2021-11-13

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT03113253 on ClinicalTrials.gov