Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid: A Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Intra-operative Blood Loss
研究概览
简要总结
This study is investigating the use of tranexamic acid (TXA) in patients with pelvis and/or hip socket fractures that require surgery. TXA is FDA-approved in patients with hemophilia for short-term use to reduce hemorrhage and the need for replacement blood during tooth extraction. However, it has also been used extensively in severely injured patients after major trauma and during elective hip and knee replacements. Previous studies indicate TXA may reduce blood loss and the need for blood transfusions while being safe for use in most patients. TXA is fairly inexpensive and easy to obtain.
The purpose of this study is to determine if TXA will make surgery in patients with pelvis and/or hip socket fractures safer and more cost efficient.
详细描述
Study candidates will be identified as they present to the University Hospital emergency room and will be recruited for enrollment. Randomization will occur by electronic randomization software. Prior to surgery, the pharmacy will be notified of an enrolled patient and will be responsible for randomization and creating either a placebo intravenous dose or a treatment study dose. Both study groups will receive the standard of care treatment for intra-operative hemorrhage control.
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
- Double (Participant, Care Provider)
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
- •Adult patients (18 years of age or greater) with acetabulum fractures and/or pelvic ring injuries that require operative fixation via an open surgical approach
排除标准
- •Revision surgery
- •Surgery occurring more than 2 weeks post-injury
- •History of blood dyscrasia or renal insufficiency
- •History of any thromboembolic disease
- •Pregnancy or nursing, color vision defects
- •History of retinal detachment/degeneration
- •Intracranial hemorrhage
- •Hypersensitivity to tranexamic acid
- •Contraceptive Use (estrogens/progestins)
- •FEIBA (anti-inhibitor coagulant complex) use
研究组 & 干预措施
Tranexamic Acid
Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.
干预措施: Tranexamic Acid (Drug)
Placebo
The control group will receive a similar volume load of normal saline and maintenance doses.
干预措施: Placebo (Drug)
结局指标
主要结局
Intra-operative Blood Loss
时间窗: Day of Surgery
次要结局
- Number of Participants That Required an Allogenic Transfusion(Perioperative (hospitalized period))
研究者
Brett Crist
Assistant Professor, Co-Director of Trauma Services, Co-Director Orthopaedic Trauma Fellowship, Department of Orthopaedic Surgery
University of Missouri-Columbia