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
  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

Resource links provided by NLM:


Further study details as provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:

Primary Outcome Measures:
  • all cause DVT [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    deep-vein thrombosis nonfatal pulmonary embolism, or death


Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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 July 28, 2014