TXA Study in Major Burn Surgery

• Status: Terminated
• Trial end date: 2019-12-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Health Hospitals
• Treatments: Tranexamic Acid

Criteria

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