Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty

October 8, 2011 updated by: JIANG Qing

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • The Center of Diagnosis and Treatment for Joint Disease, Drum Tower Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JIANG Qing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimate)

October 5, 2011

Study Record Updates

Last Update Posted (Estimate)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 8, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJDVTS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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