TXA Study in Major Burn Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2018 |
| Start Date: | April 2016 |
| End Date: | April 2019 |
| Contact: | Nicole Walker, BS |
| Email: | nicole.walker@spectrumhealth.org |
| Phone: | 616-246-6332 |
The Effect of Tranexamic Acid (TXA) on Blood Loss and Transfusion Rates in Burn Wound Surgery - A Randomized, Double-Blinded Placebo-Controlled Trial
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.
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.
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.
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.
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
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