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Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02379663
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : March 5, 2015
Information provided by (Responsible Party):
Samsung Medical Center

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

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Femur Head Necrosis Femoral Neck Fractures Drug: Rivaroxaban Drug: Enoxaparin Other: Normal saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 639 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Safety for Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty
Study Start Date : January 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Active Comparator: Oral direct Factor Xa inhibitor
Drug: Rivaroxaban
Rivaroxaban was taken orally in a dosage of 10mg once daily

Active Comparator: Low molecular weight heparin
Drug: Enoxaparin
Enoxaparin was injected subcutaneously in a dosage of 40mg once daily

Placebo Comparator: Normal Saline
Normal Saline
Other: Normal saline
subcutaneous injection of 1 cc of normal saline once daily

Primary Outcome Measures :
  1. Major wound complication [ Time Frame: 2 weeks ]
    hematoma : size, site woozing : frequency, amount, dressing change count infection : culture

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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Responsible Party: Samsung Medical Center Identifier: NCT02379663     History of Changes
Other Study ID Numbers: 2011-11-012
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: December 2014
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Femur Head Necrosis
Venous Thrombosis
Femoral Neck Fractures
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Bone Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action