Overview

TRANexamic Acid to Reduce Bleeding in BURN Surgery

Status:
Recruiting

Trial end date:
2021-09-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Collaborator:

Société Française d'Anesthésie et de Réanimation

Treatments:

Tranexamic Acid

Criteria

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