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NCT Number: NCT03113253

TRANexamic Acid to Reduce Bleeding in BURN Surgery

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.

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Key information

Conditions

Tranexamic Acid Burns Surgery Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Service de réanimation des brûlés de Mercy (CHR Metz-Thionville), Ars-Laquenexy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

Other names: Exacyl

Placebo

Drug

0.9% sodium chloride to mimic tranexamic acid

Other names: 0.9% sodium chloride

Primary outcomes

  1. 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

Secondary outcomes

  1. Need for transfusion

    Time frame: Until day 5 post surgery

    Number of blood product transfused

  2. All-cause Hospital Mortality

    Time frame: Until day 15 post surgery

    Any death during hospital stay

  3. Success of skin graft

    Time frame: Until day 15 post surgery

    Number of successful skin graft (medical assessment)

  4. Deep vein thrombosis

    Time frame: Until day 15 post surgery

    Number of deep vein thrombosis

  5. Myocardial infarction

    Time frame: Until day 15 post surgery

    Number of myocardial infarctions

  6. Stroke

    Time frame: Until day 15 post surgery

    Number of strokes

  7. Pulmonary embolism

    Time frame: Until day 15 post surgery

    Number of pulmonary embolisms

  8. Convulsion

    Time frame: Until day 15 post surgery

    Number of convulsions

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Other

Collaborators

  • Société Française d'Anesthésie et de Réanimation

Registry information

Official study title

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

Acronym: TRANBURN

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2017
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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