NCT02753816

TXA Study in Major Burn Surgery

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Corewell Health West · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tranexamic Acid
• Burn
• Major Surgery

Interventions

Type	Name	Description
DRUG	Tranexamic Acid
DRUG	Placebo Comparator

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-12-03
• Completion: 2019-12-03
• First posted: 2016-04-28
• Last updated: 2021-08-23
• Results posted: 2021-08-23

Locations

1 site across 1 country: United States