Back to resultsProphylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty
Primary Purpose
Deep Vein Thrombosis
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
prophylactic anticoagulation
Sponsored by
About this trial
This is an interventional prevention trial for Deep Vein Thrombosis focused on measuring Deep Vein Thrombosis, total hip arthroplasty, prophylactic anticoagulation, randomized study
Eligibility Criteria
Inclusion Criteria:
- Primary total hip arthroplasty
Exclusion Criteria:
- Revision hip replacement, total knee replacement, revision knee replacement, semi-hip replacement and cemented THR were excluded.
- Coagulation related disease and cancer were excluded either.
Sites / Locations
- The Center of Diagnosis and Treatment for Joint Disease, Drum Tower Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
non-prophylactic anticoagulation
prophylactic anticoagulation
Arm Description
without prophylactic anticoagulation
prophylactic anticoagulation by rivaroxaban
Outcomes
Primary Outcome Measures
all cause DVT
deep-vein thrombosis nonfatal pulmonary embolism, or death
Secondary Outcome Measures
Major DVT
major venous thromboembolism (proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death from venous thromboembolism)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01446887
Brief Title
Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty
Official Title
Phase II Study of Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
JIANG Qing
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Deep vein thrombosis (DVT) remains a life-threatening complication of arthroplasty. It remains controversial for anticoagulation strategies after total hip arthroplasty (THA). A randomized double-blind study was conducted to determine whether prophylactic anticoagulation was efficient reduce DVT after THA. subjects who underwent uncemented THA were assigned to prophylactic anticoagulation group or non- prophylactic anticoagulation group. Patients were followed up 3 months later after surgery. DVT was tested by contrast venography. Investigator also used logistic regression analysis with variable selection for obtaining the prediction model of DVT. DVT after THA was affected by personal (age) and clinical factors (mechanical compression, duration of surgery). THA with short duration of surgery did not require prophylactic anticoagulation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis
Keywords
Deep Vein Thrombosis, total hip arthroplasty, prophylactic anticoagulation, randomized study
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
non-prophylactic anticoagulation
Arm Type
No Intervention
Arm Description
without prophylactic anticoagulation
Arm Title
prophylactic anticoagulation
Arm Type
Experimental
Arm Description
prophylactic anticoagulation by rivaroxaban
Intervention Type
Other
Intervention Name(s)
prophylactic anticoagulation
Intervention Description
prophylactic anticoagulation by rivaroxaban
Primary Outcome Measure Information:
Title
all cause DVT
Description
deep-vein thrombosis nonfatal pulmonary embolism, or death
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Major DVT
Description
major venous thromboembolism (proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death from venous thromboembolism)
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary total hip arthroplasty
Exclusion Criteria:
Revision hip replacement, total knee replacement, revision knee replacement, semi-hip replacement and cemented THR were excluded.
Coagulation related disease and cancer were excluded either.
Facility Information:
Facility Name
The Center of Diagnosis and Treatment for Joint Disease, Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
12. IPD Sharing Statement
Learn more about this trial
Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty
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