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临床试验/NCT02644473
NCT02644473撤回4 期

Safety of Topical Tranexamic Acid in Total Joint Arthroplasty in High Risk Patients

Albert Einstein College of Medicine0 个研究点开始时间: 2016年2月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
撤回
主要终点
Pulmonary Embolism

研究概览

简要总结

To evaluate whether there is a difference in symptomatic thromboembolism events in the subset of patients with a history of, or risk factors for thromboembolic disease for topically applied tranexamic acid in total joint arthroplasty.

详细描述

Tranexamic acid (TXA) has been used successfully to stop bleeding after dental procedures, removal of tonsils, prostate surgery, heavy menstrual bleeding, and eye injuries, as well as in patients with hemophilia. Intravenous TXA has also been shown to reduce blood loss, reduce transfusion requirements, and decrease length of stay for patients undergoing total knee arthroplasty and total hip arthroplasty. These benefits occur without increasing risks of thromboembolism events such as pulmonary embolism, deep venous thrombosis, myocardial infarctions, and cerebrovascular events in patients without history of, or risk factors for thromboembolic disease. Topical TXA in TJA has also been demonstrated to show the above benefits without any increase risks, as well as systemic absorption of the medication that is below the effective therapeutic plasma concentration.

Preliminary retrospective studies has demonstrated that IV TXA to be safe and effective in patients with risk factors for thromboembolic events and patients with American Society of Anesthesiologists score III or IV.

Currently, there are no prospective studies on the use of either IV or topical TXA in these higher risk patients. The goal of this study is to evaluate whether there is a difference in symptomatic thromboembolism events in the subset of patients with a history of, or risk factors for thromboembolic disease for topically applied TXA in total joint arthroplasty (TJA).

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
50 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of one or more of seven risk factors for thromboembolic events - Prior DVT, PE, MI, CVA, coronary artery stent placement, CABG, or prothrombotic condition (Factor V Leiden deficiency, protein C deficiency, antiphospholipid syndrome, etc).

排除标准

  • Simultaneous bilateral, hip resurfacing, partial knee, and revision arthroplasties

研究组 & 干预措施

Tranexamic acid

Experimental

Investigators will administer topical (1.5g) TXA during total knee arthroplasty and total hip arthroplasty

干预措施: Tranexamic Acid (Drug)

Control

Placebo Comparator

干预措施: Normal saline (Drug)

结局指标

主要结局

Pulmonary Embolism

时间窗: 1 month

Myocardial infarction

时间窗: 1 month

Deep Vein Thrombosis

时间窗: 1 month

Stroke

时间窗: 1 month

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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