The Effect of Tranexamic Acid (TXA) on Blood Loss and Transfusion Rates in Burn Wound Surgery - A Randomized, Double-Blinded Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Blood Transfusion Rates, Defined Nominally (Binary) as Having at Least One Transfusion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Tranexamic Acid
1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery
干预措施: Tranexamic Acid (Drug)
Placebo
Placebo given over 10 minutes into the vein once prior to surgery
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Blood Transfusion Rates, Defined Nominally (Binary) as Having at Least One Transfusion
时间窗: First burn surgery to hospital discharge
To determine the impact of perioperative administration of Tranexamic Acid on transfusion rates in major burn surgeries.
Intraoperative Blood Loss in mL
时间窗: Intraoperative, average 122 minutes
To determine the impact of perioperative administration of Tranexamic Acid on blood loss in major burn surgeries.
次要结局
- Effect of Tranexamic Acid on the Total Length of Hospital Admission for a Large (350 cm2) Burn Injury(Hospital admission to hospital discharge)