INTRAVENOUS VERSUS INTRA-ARTICULAR ADMINISTRATION OF TRANEXAMIC ACID FOR CONTROL OF PERI-OPERATIVE BLOOD LOSS IN TOTAL KNEE REPLACEMENT SURGERIES - A RANDOMISED CONTROLLED EQUIVALANCE TRIAL.

Sri Sathya Sai Institute of Higher Medical Sciences Prasanthigram1 个研究点分布在 1 个国家目标入组 138 人开始时间: 2015年1月5日最近更新: 2017年8月6日

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 138
试验地点: 1
主要终点: Postoperative Hemoglobon drop

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is intended to test for equivalence between intraarticular and intravenous routes for administration of tranexamic acid for control of perioperative blood loss in total knee replacement in terms of efficacy and safety.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and Outcome Assessor Blinded

入排标准

年龄范围: 45.00 Year(s) 至 85.00 Year(s)（—）
性别: All

入选标准

•All patients undergoing total knee arthroplasty for primary arthroplasty knee 2.Patients who are willing to participate in the study.
•3.Patient without exclusion criteria.

排除标准

•1.Allergy to the TXA 2.H/O Coagulopathy,abnormal PT or APTT 3.Past H/O Thromboembolic event 4.Treatment with Aspirin or NSAIDS in the last week 5.plasma creatinine > 115 micro moles /litre for males And >100 micro moles/litre in females.
•6.Acute infection[eg;leukocytosis or fever] 7.Malignancy 8.MI in preceding 12 months,unstable angina 9.Patient who were given plasma in perioperative period.

结局指标

主要结局

Postoperative Hemoglobon drop

时间窗: Assessed at 5 days of surgery

次要结局

Perioperative blood loss, need for post operative blood transfusion, impairment of renal function, occurrence of deep vein thrombosis(6 weeks)

研究者

发起方

Sri Sathya Sai Institute of Higher Medical Sciences Prasanthigram

申办方类型

Research institution and hospital

研究点 (1)

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