The comparative Efficacy and Safety of Topical and Intravenous Tranexamic acid for Reducing Perioperative Blood Loss in Total Knee Arthroplasty- A Randomized Controlled Non-inferiority Trial

SUNSHINE HOSPITALS1 个研究点分布在 1 个国家目标入组 113 人开始时间: 2017年9月1日最近更新: 2017年7月17日

试验速览

阶段: 不适用
状态: 已完成
发起方: SUNSHINE HOSPITALS
入组人数: 113
试验地点: 1
主要终点: Postoperative Hemoglobin 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 non-inferiority between intraarticular and intravenous routes for administration of tranexamic acid for control of perioperative blood loss in total knee replacement surgeries 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: 40.00 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 Hemoglobin drop

时间窗: Assessed at 3 days of surgery

次要结局

Perioperative blood loss, need for post operative(blood transfusion, impairment of renal function,)

研究者

发起方

SUNSHINE HOSPITALS

申办方类型

Research institution and hospital

研究点 (1)

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