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临床试验/NCT03044041
NCT03044041已完成4 期

Topical Intra-Articular High Doses Compared With Low Doses of Tranexamic Acid to Reduce Blood Loss in Primary Total Knee Arthroplasty: A Double-Blind Randomized Controlled Trial

Thammasat University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
80
试验地点
1
主要终点
Total blood loss

研究概览

简要总结

The purpose of this study is to compare blood loss between using low dose (500 mg) and high dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in double-blind RCT

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Osteoarthritic knee who underwent primary total knee arthroplasty

排除标准

  • Abnormal coagulation or bleeding disorder
  • Allergy to tranexamic acid
  • History of thromboembolism or ischemic heart disease or cerebrovascular accident
  • chronic kidney disease stage 3-4

研究组 & 干预措施

Low dose

Experimental

single dose of intra-articular Tranexamic acid 500 miligrams

干预措施: Tranexamic Acid (Drug)

High dose

Active Comparator

Single dose of intra-articular Tranexamic acid 3 grams

干预措施: Tranexamic Acid (Drug)

结局指标

主要结局

Total blood loss

时间窗: 72 hours after TKA

Blood loos that calculated from Haemoglobin drop at 72 hours after surgery

次要结局

  • Functional score(At 6 weeks after surgery)
  • Rate of participants with infection(0-3 months after surgery)
  • Blood transfusion(0-72 hours after surgery)
  • Rate of participants with thromboembolism(At 72 hours and 2 weeks after surgery)
  • Knee ROM(At 2, 6 weeks after surgery)

研究者

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

Supakit Kanitnate

Investigator

Thammasat University

研究点 (1)

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