CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 121 enrolled
Drug / intervention
Tranexamic Acid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03113253
NCT03113253Phase 4Completed

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

Centre Hospitalier Saint Joseph Saint Luc de Lyon·interventional·Posted Apr 13, 2017·Updated Apr 4, 2024

In Brief

A Phase 4 clinical trial evaluating Tranexamic Acid and Placebo for Tranexamic Acid and 3 related conditions. Completed, enrolled 121 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 13, 2017
Enrollment StartSep 22, 2016
Primary CompletionNov 2, 2021
Study CompletionNov 13, 2021
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 9.2 years ago

Interventions

Tranexamic Aciddrug

Placebodrug

0.9% sodium chloride to mimic tranexamic acid