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
About this trial
This is an interventional prevention trial for Osteoarthritis, Hip
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
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
NCT ID
NCT02379663
First Posted
February 13, 2015
Last Updated
March 4, 2015
Sponsor
Samsung Medical Center
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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