TXA Study in Major Burn Surgery

Study Overview
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Brief Summary
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Major surgery can result in blood loss that can require a blood transfusion during and/or after surgery. Tranexamic acid (TXA) is a medication that was first introduced in the 1960's as a treatment for heavy menstrual bleeding. Over the past 20 years, it has been used and studied in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. Investigators believe tranexamic acid may possibly decrease bleeding related to major burn surgery, resulting in reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs related to your stay. In this study, prior to each surgical procedure to treat the participants burn injury, the participant will receive either the drug tranexamic acid or placebo. The placebo is a liquid that looks like the tranexamic acid medicine, but does not have any active ingredient in it. In this study, both the tranexamic acid and the placebo are considered research.

Detailed Description
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Neither the participant nor the study doctor will choose what treatment the participant gets. The participant will have an equal chance of being given the tranexamic acid or the placebo. Neither the participant nor the study doctor will know which treatment the participant is receiving. The participant will receive one 1 gram dose of either tranexamic acid or placebo immediately before surgery. The dose of tranexamic acid or placebo will be given in the participants vein over a 10-minute period. Information from the participants medical record related to their surgery and recovery time in the hospital will be collected by medical staff assisting with this study and recorded on study forms. These study forms will be labeled with the participants study number instead of their name.

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

Conditions
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Tranexamic Acid, Burn, Major Surgery

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects undergoing burn excision surgery for standard of care purposes (to include: greater than or equal to 350 cm2 of full thickness or deep partial thickness burns) 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 Baseline creatinine level greater than 2.83 mg/dL Subjects with known hypersensitivity to tranexamic acid Patients with acquired defective color vision Patients with subarachnoid hemorrhage Children Pregnant women Prisoners

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>1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery | Drug: Tranexamic Acid<br> <br> |
| Placebo Comparator: Placebo<br>Placebo given over 10 minutes into the vein once prior to surgery | Drug: Placebo Comparator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Blood Loss in mL | To determine the impact of perioperative administration of Tranexamic Acid on blood loss in major burn surgeries. | Intraoperative, average 122 minutes | 
| Blood Transfusion Rates, Defined Nominally (Binary) as Having at Least One Transfusion | To determine the impact of perioperative administration of Tranexamic Acid on transfusion rates in major burn surgeries. | First burn surgery to hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Tranexamic Acid on the Total Length of Hospital Admission for a Large (350 cm2) Burn Injury | To determine the impact of Tranexamic Acid on total hospital length of stay by comparing the hospital admission date and the hospital discharge date. This determination will take into account current burn size and location, procedures performed and their effect on wound healing and skin graft survival. | Hospital admission to hospital discharge | 

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