Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty
Phase 4
Completed
- Conditions
- Femur Head NecrosisFemoral Neck FracturesOsteoarthritis, Hip
- Interventions
- 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
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
- Secondary Outcome Measures
Name Time Method