Clinical Trial: Comparison of Topical Versus Intravenous Tranexamic Acid in TKA

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Comparison of Topical Versus Intravenous Tranexamic Acid in Primary Total Knee Arthroplasty：A Prospective Randomized Study

Brief Summary: Previous studies in both the cardiovascular and orthopedic study have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate largely without major complications . In addition, many meta-analyses have confirmed these results . However, there is little information about comparison among the different routes of TXA administration in TKA. Therefore, this study has been designed to determine which administration route of TXA is more effective and safety.

Detailed Summary:

Objectives:To assess the efficacy and safety between the two different applying routes.

Patients in this project will be randomly divided into three groups , one group is a blank group and the rest two receive either the topical or the intravenous form of tranexamic acid during unilateral TKA(total knee arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction events will be recorded to assess the safety of the tranexamic acid during a six-week follow-up for each patient.

All surgery are under general anesthesia, through direct lateral approach with cementless prosthesis.For all patients, the drain tube will be clamped and closed completely for 2 hours; then the clamp will be fully opened.


Sponsor: Shanghai Jiao Tong University School of Medicine

Current Primary Outcome: Total Blood Loss（TBL） [ Time Frame: calculated by an equation at the fifth postoperative day ]

Total Blood Loss（TBL） was calculated with equations described by Gross et al.


Original Primary Outcome: Same as current

Current Secondary Outcome: Transfusion rates [ Time Frame: from the day of surgery to the day of discharge,an expected average of 7 days ]

Include The number of units of perioperative blood transfusions, both intraoperative and postoperative, over the course of the patient's hospital stay


Original Secondary Outcome: Same as current

Information By: Shanghai Jiao Tong University School of Medicine

Dates:
Date Received: March 15, 2015
Date Started: September 2014
Date Completion: July 2015
Last Updated: March 25, 2015
Last Verified: March 2015