Efficacy of Tranexamic Acid (TXA) in Humerus ORIF
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Blood loss
研究概览
简要总结
The purpose of this study is to determine if administration of tranexamic acid (TXA), a clotting agent, will decrease blood loss, the need for transfusion, and reduce the likelihood of wound complications such as infection. Investigators will also see if the drug can effectively decrease operative time and length of hospitalization.
详细描述
Single-center randomized controlled trial, parallel two-arm design allocation 1:1 exposed-control design to determine if TXA aids in prevention of blood loss in upper extremity trauma, specifically humerus fractures. Patient population includes male and female adults with no history of thromboses who suffered an isolated humeral injury. Patients will be evaluated at Allegheny General Hospital (AGH) as surgical candidates and allocated to the exposure group (receive TXA) or the control group (saline placebo). Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery. The control group will have saline administered 10 minutes prior to surgery. Patients will be seen in follow up at both 2 weeks and 6 weeks postoperatively, as well as followed through the electronic medical record (EMR).
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age 18-100 years
- •Isolated proximal humerus or humeral shaft fracture undergoing open reduction internal fixation.
- •Must be able to read and understand English and consent for themselves.
排除标准
- •Allergy to TXA.
- •Acquired disturbances of color vision.
- •History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA.
- •Pregnant or breastfeeding.
- •Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement.
- •Renal impairment (creatinine above 1.2 in women, creatinine above 1.4 in men)
- •Refusal of blood products
- •Subarachnoid hemorrhage
- •Disseminated intravascular coagulation
研究组 & 干预措施
Treatment Arm
Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery
干预措施: Tranexamic acid (TXA) (Drug)
Control Group
The control group will have saline administered 10 minutes prior to surgery.
干预措施: Saline (Other)
结局指标
主要结局
Blood loss
时间窗: Intraoperatively
The estimated total blood loss measured intraoperatively. This will be done by estimating absorbed drainage by surgical gauze and adding this to total volume in suction canister. Total volume of irrigation used will be subtracted from this total to give an estimate of intraoperative blood loss.
次要结局
- Operative Time(From the start of surgical procedure through the completion of the surgical procedure)
- Duration of follow-up(Through study completion, an average of one year.)
- Complications (DVT, PE, stroke)(through study completion, an average of one year)
研究者
Peter Tang
Associate Professor of Orthopaedic Surgery
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)