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临床试验/NCT02867163
NCT02867163已完成不适用

Does the Intraoperative Administration of Tranexamic Acid (TXA) Increase the Incidence of Deep Venous Thrombosis in Total Knee Arthroplasty?

University of New Mexico1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年5月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Deep Vein Thrombosis

研究概览

简要总结

This is an observational trial to estimate the incidence of deep vein thrombosis (DVT) in total knee replacement patients who received an intraoperative dose of tranexamic acid.

详细描述

This study is anticipated to consist of 30 participants over 18 years of age scheduled for total knee arthroplasty at Sandoval Regional Medical Center with administered intraoperative tranexamic acid, who do not meet the exclusion criteria. The patients will be examined on postoperative day 1. Lower-extremity ultrasound will be used to screen for deep vein thrombosis (DVT). Incidence data for DVT will then be compared with the historical incidence rate at our institution for total knee arthroplasty without the use of tranexamic acid, which is approximately 12%. Patients found on screening to have deep vein thrombosis will be referred for appropriate care.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients scheduled for total knee arthroplasty at Sandoval Regional Medical Center with an intraoperative dose of tranexamic acid

排除标准

  • Previous deep vein thrombosis or pulmonary embolism episode
  • Known coronary artery disease or peripheral vascular disease
  • Previously diagnosed hypercoagulable states (e.g. Leiden factor V, antiphospholipid antibody, protein C or S deficiency)
  • Pregnancy
  • Creatinine clearance less than 30 ml/min
  • Non-fluency in English

研究组 & 干预措施

Knee replacement patients receiving TXA

Patients who receive tranexamic acid during total knee replacement surgery

干预措施: Tranexamic Acid (Drug)

结局指标

主要结局

Deep Vein Thrombosis

时间窗: One day

Incidence of deep vein thrombosis diagnosed by ultrasound scan on postoperative day 1

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Siegel

Assistant Professor

University of New Mexico

研究点 (1)

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