TXA Study in Major Burn Surgery

Not Applicable

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Comparator	Placebo given over 10 minutes into the vein once prior to surgery
Tranexamic Acid	Tranexamic Acid	1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effect of Tranexamic Acid on the Total Length of Hospital Admission for a Large (350 cm2) Burn Injury	Hospital admission to hospital discharge	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.