Trial | NCT03113253  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    121
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.
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 Started
Sep 22
2016
Primary Completion
Mar 01
2022
Anticipated
Study Completion
Mar 01
2022
Anticipated
Last Update
Feb 09
2022

Drug Tranexamic Acid

  • Other names: Exacyl

Drug Placebo

0.9% sodium chloride to mimic tranexamic acid

  • Other names: 0.9% sodium chloride

Tranexamic Acid Experimental

Patient will receive: 1g of tranexamic acid by slow intravenous injection 1g of tranexamic acid by syringe pump during 8 hours

Placebo Placebo Comparator

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

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
No Results Posted