TRANexamic Acid to Reduce Bleeding in BURN Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tranexamic Acid, Burns, Surgery, Wounds and Injuries

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid<br>Patient will receive: 1g of tranexamic acid by slow intravenous injection 1g of tranexamic acid by syringe pump during 8 hours | Drug: Tranexamic Acid<br> <br> * Other names: Exacyl;|
| Placebo Comparator: Placebo<br>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 | Drug: Placebo<br>* 0.9% sodium chloride to mimic tranexamic acid<br>* Other names: 0.9% sodium chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss (mL / cm² excised) | To determine the impact of tranexamic acid on blood loss in burn surgeries | Until day 5 post surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burn, Surgery, Tranexamic Acid, Excision