NCT03113253

TRANexamic Acid to Reduce Bleeding in BURN Surgery

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Tranexamic Acid
• Burns
• Surgery
• Wounds and Injuries

Interventions

Type	Name	Description
DRUG	Tranexamic Acid
DRUG	Placebo	0.9% sodium chloride to mimic tranexamic acid

Timeline

• Start date: 2016-09-22
• Primary completion: 2021-11-02
• Completion: 2021-11-13
• First posted: 2017-04-13
• Last updated: 2024-04-04

Locations

4 sites across 1 country: France