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临床试验/NCT02373969
NCT02373969已完成不适用

Thromboelastogram During Surgery for Total Knee Replacement With Tourniquet Application and Single Dose Tranexamic Acid

Rambam Health Care Campus0 个研究点目标入组 30 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
主要终点
Change in coagulation status during and after surgery compared to pre-surgery

研究概览

简要总结

Verify the changes in coagulation system during total knee replacement surgery with tranexamic acid single bolus infusion.

详细描述

The study was set to reveal changes in the coagulation and fibrinolytic systems during total knee surgery and especially during tourniquet placement, tourniquet removal and revascularization of ischemic limb, after tranexamic acid single bolus infusion, and at post operative day 1.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Osteoarthrosis
  • TKR operation elective
  • ASA I-III

排除标准

  • TKR due to any reason but osteoarthrosis
  • known coagulation problems
  • platelets < 100,000/DcL
  • Hb < 12 g%
  • past thrombo-embolic event
  • treatment with aspiring during last week
  • treatment with NSAID's during last 48 hours
  • malignancy
  • known allergy to tranexamic acid
  • general anesthesia

结局指标

主要结局

Change in coagulation status during and after surgery compared to pre-surgery

时间窗: During and after surgery compared to pre-surgery

Change in fibrinolytic activity during and after surgery compared to pre-surgery

时间窗: During and after surgery compared to pre-surgery

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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