We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01446887
First Posted: October 5, 2011
Last Update Posted: October 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JIANG Qing, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  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
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

Resource links provided by NLM:


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

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


Secondary Outcome Measures:
  • Major DVT [ Time Frame: 7 days ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

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 Submitted: September 28, 2011
First Posted: October 5, 2011
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