Safety Study of Stopping Thromboprophylaxis Based on Ultrasound Results After Total Knee Replacement
October 27, 2010 updated by: University Hospital, Caen
9-10 Days Versus Prolonged Thromboprophylaxis in Patients Without Evidence of Ultrasound Proximal Thromboembolism After Total Knee Joint Replacement: a Randomized Controlled Trial
The purpose of this study is to determine whether stopping Low Molecular Weight Heparin (LMWH) thromboprophylaxis is safe after total knee joint replacement.
The investigators select patients without proximal thromboembolism assessed by bilateral venous ultrasound examination 7-10 days after surgery.
the investigators hypothesis is that stopping thromboprophylaxis is equally effective than prolonging thromboprophylaxis in order to prevent post-surgery complications in this population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
850
Phase
- Phase 4
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
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Alençon, France, 61014
- Hospital Alençon
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Angers, France
- Hospital University Angers
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Bois-Guillaume, France, 76230
- Clinique du Cèdre
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Caen, France, 14033
- Caen University hospital
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Chalons sur Saone, France, 71100
- Clinique St Marie
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Foix, France, 0941
- Hospital Val D'ariège
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La Roche sur Yon, France, 85295
- Hospital La Roche sur Yon
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Le Chesnay, France, 78150
- Mignot Hospital
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Lievin, France, 62800
- Polyclinique de Riaumont
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Lille, France, 59037
- Hospital University Lille
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Mayenne, France
- Hospital Nord Mayenne
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Montluçon, France, 03100
- Montluçon Hospital
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Poitiers, France, 86021
- Poitiers University Hospital
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Reims, France, 51092
- Reims University Hospital
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Reims, France, 51100
- Clinique St André
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Roubaix, France, 59100
- Clinique St Jean
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Toulouse, France, 31077
- Clinique St Jean Languedoc
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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
46 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- First total knee joint replacement
- Signed informed consent
Non-inclusion Criteria:
- History of venous thromboembolism/major bleeding/Heparin induced thrombopenia
- Active cancer
- Long-term anticoagulation
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: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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All cause mortality
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Thromboembolism occuring between day 7-35 ;
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Major bleeding occuring between day 7-35 ;
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LMWH induced thrombopenia
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marie-Thérèse Barrellier, MD, Côte de Nacre University Hospital
- Study Chair: Claude Vielpeau, MD, Côte de Nacre University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
June 1, 2004
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
August 9, 2006
First Submitted That Met QC Criteria
August 9, 2006
First Posted (Estimate)
August 10, 2006
Study Record Updates
Last Update Posted (Estimate)
October 28, 2010
Last Update Submitted That Met QC Criteria
October 27, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRC-Prothege
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.