TRANexamic Acid to Reduce Bleeding in BURN Surgery

Phase 4

Completed

• Conditions: Tranexamic Acid; Burns; Wounds and Injuries; Surgery
• Interventions: Drug: Tranexamic Acid; Drug: Placebo

• Registration Number: NCT03113253
• Lead Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

Brief 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.

Study Timeline

• Study Start: 2016-09-22
• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-13
• Primary Completion: 2021-11-02
• Study Completion: 2021-11-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid	Tranexamic Acid	Patient will receive: * 1g of tranexamic acid by slow intravenous injection * 1g of tranexamic acid by syringe pump during 8 hours
Placebo	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

Primary Outcome Measures

Name	Time	Method
Blood loss (mL / cm² excised)	Until day 5 post surgery	To determine the impact of tranexamic acid on blood loss in burn surgeries

Secondary Outcome Measures

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

Trial Locations

Locations (4)

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

Centre Commun de Traitement des Brûlés - Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Centre des brûlés inter-régional Méditerranée - Hôpital de la Conception; 🇫🇷 Marseille, France

Centre Hospitalier Saint Joseph Saint Luc; 🇫🇷 Lyon, France