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Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT01446887
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : October 12, 2011
Sponsor:
Information provided by (Responsible Party):
JIANG Qing, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Other: prophylactic anticoagulation Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase II Study of Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty
Study Start Date : January 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: non-prophylactic anticoagulation
without prophylactic anticoagulation
Experimental: prophylactic anticoagulation
prophylactic anticoagulation by rivaroxaban
Other: prophylactic anticoagulation
prophylactic anticoagulation by rivaroxaban



Primary Outcome Measures :
  1. all cause DVT [ Time Frame: 7 days ]
    deep-vein thrombosis nonfatal pulmonary embolism, or death


Secondary Outcome Measures :
  1. Major DVT [ Time Frame: 7 days ]
    major venous thromboembolism (proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death from venous thromboembolism)



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Ages Eligible for Study:   35 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446887


Locations
China, Jiangsu
The Center of Diagnosis and Treatment for Joint Disease, Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Sponsors and Collaborators
JIANG Qing

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
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011

Keywords provided by JIANG Qing, 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