Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Deep Vein Thrombosis |
Other: prophylactic anticoagulation |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Phase II Study of Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty |
- all cause DVT [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]deep-vein thrombosis nonfatal pulmonary embolism, or death
- Major DVT [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]major venous thromboembolism (proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death from venous thromboembolism)
| Study Start Date: | January 2007 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: non-prophylactic anticoagulation
without prophylactic anticoagulation
|
|
|
Experimental: prophylactic anticoagulation
prophylactic anticoagulation by rivaroxaban
|
Other: prophylactic anticoagulation
prophylactic anticoagulation by rivaroxaban
|
Eligibility| Ages Eligible for Study: | 35 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | JIANG Qing, Director, The Center of Diagnosis and Treatment for Joint Disease, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| ClinicalTrials.gov Identifier: | NCT01446887 History of Changes |
| Other Study ID Numbers: | NJDVTS |
| Study First Received: | September 28, 2011 |
| Last Updated: | October 8, 2011 |
| Health Authority: | China: Ministry of Health |
Keywords provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
|
Deep Vein Thrombosis total hip arthroplasty prophylactic anticoagulation randomized study |
Additional relevant MeSH terms:
|
Thrombosis Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013