Clinical trial NCT02753816: TXA Study in Major Burn Surgery
Official title: The Effect of Tranexamic Acid (TXA) on Blood Loss and Transfusion Rates in Burn Wound Surgery - A Randomized, Double-Blinded Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tranexamic Acid
Burn
Major Surgery
Keywords: Tranexamic Acid
Burn
Surgery
Tangential
Excision
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Intraoperative Blood Loss in mL
timeFrame: Intraoperative, average 122 minutes
measure: Blood Transfusion Rates, Defined Nominally (Binary) as Having at Least One Transfusion
timeFrame: First burn surgery to hospital discharge
Secondary outcomes:
measure: Effect of Tranexamic Acid on the Total Length of Hospital Admission for a Large (350 cm2) Burn Injury
timeFrame: Hospital admission to hospital discharge
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health Hospital
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: Elizabeth Steensma, MD
role: PRINCIPAL_INVESTIGATOR
References:
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