TRANexamic Acid to Reduce Bleeding in BURN Surgery (TRANBURN)

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Status and phase: Completed; Phase 4

Conditions: Surgery; Tranexamic Acid; Burns; Wounds and Injuries

Treatments: Drug: Placebo; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03113253

TRANBURN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 2 patient groups, including a placebo group

Tranexamic Acid

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo