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Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

Primary Purpose

Osteoarthritis, Hip, Femur Head Necrosis, Femoral Neck Fractures

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Rivaroxaban
Enoxaparin
Normal saline
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoarthritis, Hip

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Oral direct Factor Xa inhibitor

    Low molecular weight heparin

    Normal Saline

    Arm Description

    Rivaroxaban

    Enoxaparin

    Normal Saline

    Outcomes

    Primary Outcome Measures

    Major wound complication
    hematoma : size, site woozing : frequency, amount, dressing change count infection : culture

    Secondary Outcome Measures

    Full Information

    First Posted
    February 13, 2015
    Last Updated
    March 4, 2015
    Sponsor
    Samsung Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02379663
    Brief Title
    Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty
    Official Title
    Efficacy and Safety for Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Samsung Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Hip, Femur Head Necrosis, Femoral Neck Fractures

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    639 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oral direct Factor Xa inhibitor
    Arm Type
    Active Comparator
    Arm Description
    Rivaroxaban
    Arm Title
    Low molecular weight heparin
    Arm Type
    Active Comparator
    Arm Description
    Enoxaparin
    Arm Title
    Normal Saline
    Arm Type
    Placebo Comparator
    Arm Description
    Normal Saline
    Intervention Type
    Drug
    Intervention Name(s)
    Rivaroxaban
    Intervention Description
    Rivaroxaban was taken orally in a dosage of 10mg once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Enoxaparin
    Intervention Description
    Enoxaparin was injected subcutaneously in a dosage of 40mg once daily
    Intervention Type
    Other
    Intervention Name(s)
    Normal saline
    Intervention Description
    subcutaneous injection of 1 cc of normal saline once daily
    Primary Outcome Measure Information:
    Title
    Major wound complication
    Description
    hematoma : size, site woozing : frequency, amount, dressing change count infection : culture
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

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