Tranexamic Acid During Excisional Burn Surgery

Study Overview
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Brief Summary
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The purpose of this study is to access the efficacy of the drug tranexamic acid in reducing blood loss during burn excision surgery.

Detailed Description
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This study is a double-blinded, randomized placebo-controlled trial. After informed consent patients will be randomized in either the placebo or the tranexamic acid group (1500 mg). The intervention will be conducted during burn excisional surgery. First, the participant with be anesthetized, whereafter the study medication is administered.

Official Title
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Tranexamic Acid During Excisional Burn Surgery

Conditions
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Blood Loss, Burns, Blood Loss, Surgical, Tranexamic Acid, Burn Excisional Surgery

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: Patients scheduled for burn excisional surgery An expected blood loss of ≥250ml based on the estimation by the performing surgeon on the basis of: (1) ≥ 2 % body surface area excision planned (100-200 cc / % total body surface area, (2) operation technique used (some techniques show more blood loss than others), (3) time after burn trauma (i.e. expected healing) ≥18 year informed consent of patient or legal representative Patients or legal representative should have enough knowledge of Dutch to provide informed consent Exclusion Criteria: Patients with a recorded coagulopathy in their history The use of anticoagulants (except acetylsalicylic acid or (intensive) prophylaxis low molecular weight heparin >12 hours before surgery) Severe kidney failure (creatinine >500 μmol/L) Allergy for tranexamic acid Diagnosis of acute venous-/arterial thrombosis within 3 months before inclusion Diffuse intravascular coagulation (based on the diffuse intranasal coagulation-score >5) Pregnancy Active breastfeeding History of epilepsy

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 arm<br>Tranexamic acid 1500 mg dissolved in 100 ml sodium chloride, once, directly after anesthetizing the participant. In participants with renal insufficiency (creatinine >120 umol/L) the dose will be reduced to 1000 mg. | Drug: Tranexamic acid<br>* Tranexamic acid 1500 mg<br>|
| Placebo Comparator: Placebo arm<br>100ml sodium chloride 0.9%, once, directly after anesthetizing the participant. | Drug: Placebo<br>* Placebo, sodium chloride 0.9%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | Volume of blood loss measured during surgery. | During burn excisional surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Mortality | % of mortality in patients participating in this study. | During total admittance of the patient | 
| Length of stay in days | Number of days admitted after burn trauma. | The length of stay will be evaluated after 3 months after inclusion. If, after 3 months, the patient is still admitted, the status of hospitalisation will be check after an addition 3 months. | 
| Graft failure in % of total graft | % of graft failure of the total graft. | During burn excisional surgery | 
| Cardiopulmonary complications | i.e. pulmonary embolism, arterial embolism. | Within the first 30 days after burn excisional surgery | 
| Neurologic complications | i.e. stroke of epilepsy | Within the first 30 days after burn excisional surgery | 
| The need for escape medication | Out of protocol administration of tranexamic acid based on massive blood loss. | During burn excisional surgery | 
| Extend of fibrinolysis during burn excisional surgery | Measured by ROTEM analysis | During burn excisional surgery | 
| Strength of blood clot | Analysis will be performed using (electron) microscope to investigate: strength, thickness, structure of fibrin, fibrin clot networks and cell disposition within the blood clot. | During burn excisional surgery | 
| Transfusion requirements | Number of transfusions in the perioperative phase. | Perioperative, within the first day after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood loss, Tranexamic Acid, Burn excisional surgery, Burns