Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JIANG Qing, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier:
NCT01446887
First received: September 28, 2011
Last updated: October 8, 2011
Last verified: October 2011

September 28, 2011
October 8, 2011
January 2007
December 2010   (final data collection date for primary outcome measure)
all cause DVT [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
deep-vein thrombosis nonfatal pulmonary embolism, or death
Same as current
Complete list of historical versions of study NCT01446887 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Deep Vein Thrombosis
Other: prophylactic anticoagulation
prophylactic anticoagulation by rivaroxaban
  • No Intervention: non-prophylactic anticoagulation
    without prophylactic anticoagulation
  • Experimental: prophylactic anticoagulation
    prophylactic anticoagulation by rivaroxaban
    Intervention: Other: prophylactic anticoagulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
February 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
35 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01446887
NJDVTS
Yes
JIANG Qing, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
JIANG Qing
Not Provided
Not Provided
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP