TRANexamic Acid to Reduce Bleeding in BURN Surgery (TRANBURN)

April 3, 2024 updated by: Centre Hospitalier Saint Joseph Saint Luc de Lyon

The Effect of Tranexamic Acid (TXA) on Blood Loss in Burn Surgery - A Randomized, Double-Blinded Placebo-Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The first aim of the study is to demonstrate that tranexamic acid help limit blood loss and reduces the use of blood products.

Secondary objectives are to evaluate impact of tranexamic acid on mortality, success of skin grafts and occurrence of deep vein thrombosis or myocardial infarction.

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Ars-Laquenexy, France
        • Service de réanimation des brûlés de Mercy (CHR Metz-Thionville)
      • Lyon, France
        • Centre Hospitalier Saint Joseph Saint Luc
      • Lyon, France, 69437
        • Centre Commun de Traitement des Brûlés - Hôpital Edouard Herriot
      • Marseille, France
        • Centre des brûlés inter-régional Méditerranée - Hôpital de la Conception

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects undergoing burn excision surgery for standard of care purposes
  • Male or female >= 18 years of age
  • Subject or subject's medical decision maker agrees to participate in this study and provides informed consent

Exclusion Criteria:

  • Subjects with a history of hypercoagulopathy, deep vein thrombosis (DVT), pulmonary embolism
  • Renal impairment
  • Subjects with known hypersensitivity to tranexamic acid
  • Consecutive fibrinolytic states to coagulopathy
  • History of convulsions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranexamic Acid

Patient will receive:

  • 1g of tranexamic acid by slow intravenous injection
  • 1g of tranexamic acid by syringe pump during 8 hours
Drug: Tranexamic Acid
Other Names:
  • Exacyl
Placebo Comparator: Placebo

Patient will receive:

  • 10 mL of 0.9% sodium chloride by slow intravenous injection
  • 48 mL of 0.9% sodium chloride by syringe pump during 8 hours
Drug: Placebo
0.9% sodium chloride to mimic tranexamic acid
Other Names:
  • 0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss (mL / cm² excised)
Time Frame: Until day 5 post surgery
To determine the impact of tranexamic acid on blood loss in burn surgeries
Until day 5 post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for transfusion
Time Frame: Until day 5 post surgery
Number of blood product transfused
Until day 5 post surgery
All-cause Hospital Mortality
Time Frame: Until day 15 post surgery
Any death during hospital stay
Until day 15 post surgery
Success of skin graft
Time Frame: Until day 15 post surgery
Number of successful skin graft (medical assessment)
Until day 15 post surgery
Deep vein thrombosis
Time Frame: Until day 15 post surgery
Number of deep vein thrombosis
Until day 15 post surgery
Myocardial infarction
Time Frame: Until day 15 post surgery
Number of myocardial infarctions
Until day 15 post surgery
Stroke
Time Frame: Until day 15 post surgery
Number of strokes
Until day 15 post surgery
Pulmonary embolism
Time Frame: Until day 15 post surgery
Number of pulmonary embolisms
Until day 15 post surgery
Convulsion
Time Frame: Until day 15 post surgery
Number of convulsions
Until day 15 post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Collaborators

Société Française d'Anesthésie et de Réanimation

Investigators

  • Principal Investigator: Mathieu Fontaine, MD, PhD, Saint Joseph Saint Luc Hospital, Burn Intensive Care Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2016

Primary Completion (Actual)

November 2, 2021

Study Completion (Actual)

November 13, 2021

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRANBURN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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