Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

Efficacy and Safety for Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

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

Study Overview

• Status: Completed
• Conditions: Femur Head Necrosis; Osteoarthritis, Hip; Femoral Neck Fractures
• Intervention / Treatment: Drug: Rivaroxaban; Drug: Enoxaparin; Other: Normal saline

• Study Type: Interventional
• Enrollment (Actual): 639
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral direct Factor Xa inhibitor; Rivaroxaban	Drug: Rivaroxaban; Rivaroxaban was taken orally in a dosage of 10mg once daily
Active Comparator: Low molecular weight heparin; Enoxaparin	Drug: Enoxaparin; Enoxaparin was injected subcutaneously in a dosage of 40mg once daily
Placebo Comparator: Normal Saline	Other: Normal saline; subcutaneous injection of 1 cc of normal saline once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major wound complication	hematoma : size, site woozing : frequency, amount, dressing change count infection : culture	2 weeks

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: February 13, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Estimate): March 5, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Fractures, Bone; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Embolism and Thrombosis; Bone Diseases; Femoral Fractures; Hip Injuries; Osteonecrosis; Osteoarthritis; Hip Fractures; Necrosis; Thrombosis; Venous Thrombosis; Osteoarthritis, Hip; Femoral Neck Fractures; Femur Head Necrosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Enoxaparin
• Other Study ID Numbers: 2011-11-012