Burns, Surgery, Tranexamic Acid, Wounds and Injuries
Conditions
Keywords
Tranexamic Acid, Burn, Surgery, Excision
Brief 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.
Detailed 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.
Interventions
DRUGTranexamic Acid
DRUGPlacebo
0.9% sodium chloride to mimic tranexamic acid
Sponsors
Société Française d'Anesthésie et de Réanimation
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss (mL / cm² excised) | Until day 5 post surgery | To determine the impact of tranexamic acid on blood loss in burn surgeries |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Hospital Mortality | Until day 15 post surgery | Any death during hospital stay |
| Success of skin graft | Until day 15 post surgery | Number of successful skin graft (medical assessment) |
| Deep vein thrombosis | Until day 15 post surgery | Number of deep vein thrombosis |
| Need for transfusion | Until day 5 post surgery | Number of blood product transfused |
| Stroke | Until day 15 post surgery | Number of strokes |
| Pulmonary embolism | Until day 15 post surgery | Number of pulmonary embolisms |
| Convulsion | Until day 15 post surgery | Number of convulsions |
| Myocardial infarction | Until day 15 post surgery | Number of myocardial infarctions |
Countries
France
Outcome results
None listed