Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty
Phase II Study of Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2007
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 28, 2011
CompletedFirst Posted
Study publicly available on registry
October 5, 2011
CompletedOctober 12, 2011
October 1, 2011
3.9 years
September 28, 2011
October 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
all cause DVT
deep-vein thrombosis nonfatal pulmonary embolism, or death
7 days
Secondary Outcomes (1)
Major DVT
7 days
Study Arms (2)
non-prophylactic anticoagulation
NO INTERVENTIONwithout prophylactic anticoagulation
prophylactic anticoagulation
EXPERIMENTALprophylactic anticoagulation by rivaroxaban
Interventions
prophylactic anticoagulation by rivaroxaban
Eligibility Criteria
You may qualify if:
- Primary total hip arthroplasty
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- JIANG Qinglead
Study Sites (1)
The Center of Diagnosis and Treatment for Joint Disease, Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, The Center of Diagnosis and Treatment for Joint Disease
Study Record Dates
First Submitted
September 28, 2011
First Posted
October 5, 2011
Study Start
January 1, 2007
Primary Completion
December 1, 2010
Study Completion
February 1, 2011
Last Updated
October 12, 2011
Record last verified: 2011-10