Blood Loss Clinical Trial
Official title:
Comparison of Topical and Intravenous Tranexamic Acid on Blood Loss and Transfusion Rates in Total Hip Arthroplasty
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 。
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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