Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

Phase 4

Completed

• Conditions: Femur Head Necrosis; Femoral Neck Fractures; Osteoarthritis, Hip
• Interventions: Other: Normal saline; Drug: Rivaroxaban; Drug: Enoxaparin

• Registration Number: NCT02379663
• Lead Sponsor: Samsung Medical Center

Brief Summary

This prospective study compares an oral direct factor Xa inhibitor with LMWH for thromboprophylaxis in the patients undergoing THA.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-12
• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-03-04
• Last Update Submitted: 2015-03-04
• Study First Posted: 2015-03-05
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 639

Inclusion Criteria

• Male or female without childbearing potential aged ≥20 years who were scheduled for elective primary THA

Exclusion Criteria

• recent history of active bleeding or VTE
• known genetic disorder associated with bleeding tendency or any condition related with an increased risk of bleeding
• persistent blood pressure of ≥160mmHg systolic and/or ≥100 mmHg diastolic at baseline
• myocardial infarction or cerebrovascular accident within three months of the scheduled surgery
• major surgery in the prior three months
• renal insufficiency with a creatinine clearance <60mL/min , hepatic failure combined with coagulopathy, or thrombocytopenia (platelets < 100,000/mm³), or planned indwelling epidural catheter for > 6 hours after the end of surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal saline	Normal Saline
Oral direct Factor Xa inhibitor	Rivaroxaban	Rivaroxaban
Low molecular weight heparin	Enoxaparin	Enoxaparin

Primary Outcome Measures

Name	Time	Method
Major wound complication	2 weeks	hematoma : size, site woozing : frequency, amount, dressing change count infection : culture