Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty

Phase 3

Completed

• Conditions: Blood Loss
• Interventions: Drug: 0.9% sodium chloride; Drug: tranexamic acid

• Registration Number: NCT02312440
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief 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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-12-06
• Study First Posted: 2014-12-09
• Status Verified: 2015-05
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Last Update Submitted: 2015-11-28
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

1. Consented to join in our project.
2. Adult patients (greater than 18 years old)
3. Patients scheduled for primary unilateral hip arthroplasty Patients for Ruijin hospital, Shanghai, China

Exclusion Criteria

1. Patients who refuse to sign the Inform Consent
2. Had an allergy to TXA.
3. long-term bed >=3 weeks.
4. Using anticoagulant drugs within a week.
5. Coagulopathy (preoperative platelet count <150,000/mm3, INR>1.4, prolonged Activated Partial Thromboplastin Time，Prothrombin Time ，or thrombin time (>1.4 times longer than normal)
6. Pregnancy
7. Breastfeeding
8. Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; renal dysfunction ( glomerular filtration rate<60); or hepatic disfunction(glutamic-pyruvic transaminase>80 or glutamic oxalacetic transaminase>80).Retinopathy (disturbances of color vision).
9. History of thromboembolic disease: .
10. Been participating or been participated within a year in another clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group1	0.9% sodium chloride	60 Milliliters（ml）Normal saline (0.9% sodium chloride) will be applied by soaking the hip cavity for at least 3 minutes before wound closure and then sucked away.
Group2	tranexamic acid	two-dose intravenous tranexamic acid will be applied as follow: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline (0.9% sodium chloride),the first dose 15' prior to skin incision and the second dose at 180' after the first dosage.
Group 3	tranexamic acid	3g Tranexamic Acid diluted to 60 Milliliters（ml） with normal saline (0.9% sodium chloride) will be applied by soaking the hip cavity for at least 3 minutes before wound closure and then sucked away.

Primary Outcome Measures

Name	Time	Method
Total Blood Loss（TBL）	estimated by an equation at the fifth postoperative day	Total Blood Loss（TBL） was estimated with equations described by Gross et al.

Secondary Outcome Measures

Name	Time	Method
Transfusion rates	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
Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary embolism)	twelve weeks after surgery	Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE)
drainage output	ti will be recorded at the first day and the second day after surgery	The amount of blood collected by a drain attached to the hip is measured 48 hours after surgery
other thromboembolic event	twelve weeks after surgery	Clinically proven Acute Myocardial Infarction 、 acute kidney infarction or cerebral infarction

Trial Locations

Locations (1)

Orthopedic Department of Ruijin hospital; 🇨🇳 Shanghai, Shanghai, China