NCT02312440

Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty

Comparison of Topical and Intravenous Tranexamic Acid on Blood Loss and Transfusion Rates in Total Hip Arthroplasty

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Recently, there has been interest in applying tranexamic acid topically before the closure of surgical wounds in total hip replacement. It has the advantages of ease of application, maximum concentration at the site of bleeding, minimising its systematic absorption and, potentially , decline the risks for systematic side-effects 。

Detailed description

Objectives:To assess the efficacy and safety between the two different applying routes. Patients in this project are randomly divided into three groups , one group is a blank group and the rest two groups receive either the topical or the intravenous form of tranexamic acid during unilateral THA(total hip arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while the events of Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction 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 is clamped and closed completely for 2 hours; then the clamp is fully opened.

Conditions

• Blood Loss

Interventions

Type	Name	Description
DRUG	0.9% sodium chloride	The normal saline solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet.
DRUG	tranexamic acid	The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet.
DRUG	tranexamic acid	The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the circuit nurse and the circuit nurse will ask the anesthetist to apply the solution intravenously before tourniquet deflation. The dosage and applying route can also be looked up in doctor's order sheet. 60 Milliliters（ml） by irrigation for 3 minutes before wound closure.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2014-12-09
• Last updated: 2015-12-02

Locations

1 site across 1 country: China