Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty

Overview

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.

Full Title of Study: “Phase II Study of Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2010

Interventions

  • Other: prophylactic anticoagulation
    • prophylactic anticoagulation by rivaroxaban

Arms, Groups and Cohorts

  • No Intervention: non-prophylactic anticoagulation
    • without prophylactic anticoagulation
  • Experimental: prophylactic anticoagulation
    • prophylactic anticoagulation by rivaroxaban

Clinical Trial Outcome Measures

Primary Measures

  • all cause DVT
    • Time Frame: 7 days
    • deep-vein thrombosis nonfatal pulmonary embolism, or death

Secondary Measures

  • Major DVT
    • Time Frame: 7 days
    • major venous thromboembolism (proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death from venous thromboembolism)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • JIANG Qing
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: JIANG Qing, Director, The Center of Diagnosis and Treatment for Joint Disease – The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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