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Safety Study of Stopping Thromboprophylaxis Based on Ultrasound Results After Total Knee Replacement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00362492
First Posted: August 10, 2006
Last Update Posted: October 28, 2010
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:
University Hospital, Caen
  Purpose
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.

Condition Intervention Phase
Thromboembolism Arthroplasty Replacement, Knee Procedure: Bilateral ultrasound examination 7+/- 2 after surgery Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 9-10 Days Versus Prolonged Thromboprophylaxis in Patients Without Evidence of Ultrasound Proximal Thromboembolism After Total Knee Joint Replacement: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Thromboembolism occuring between day 7-35 ;
  • Major bleeding occuring between day 7-35 ;
  • LMWH induced thrombopenia
  • All cause mortality

Estimated Enrollment: 850
Study Start Date: June 2004
Study Completion Date: June 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   46 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT00362492


Locations
France
Hospital Alençon
Alençon, France, 61014
Hospital University Angers
Angers, France
Clinique du Cèdre
Bois-Guillaume, France, 76230
Caen University hospital
Caen, France, 14033
Clinique St Marie
Chalons sur Saone, France, 71100
Hospital Val D'ariège
Foix, France, 0941
Hospital La Roche sur Yon
La Roche sur Yon, France, 85295
Mignot Hospital
Le Chesnay, France, 78150
Polyclinique de Riaumont
Lievin, France, 62800
Hospital University Lille
Lille, France, 59037
Hospital Nord Mayenne
Mayenne, France
Montluçon Hospital
Montluçon, France, 03100
Poitiers University Hospital
Poitiers, France, 86021
Reims University Hospital
Reims, France, 51092
Clinique St André
Reims, France, 51100
Clinique St Jean
Roubaix, France, 59100
Clinique St Jean Languedoc
Toulouse, France, 31077
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Marie-Thérèse Barrellier, MD Côte de Nacre University hospital
Study Chair: Claude Vielpeau, MD Côte de Nacre University hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00362492     History of Changes
Other Study ID Numbers: PHRC-Prothege
First Submitted: August 9, 2006
First Posted: August 10, 2006
Last Update Posted: October 28, 2010
Last Verified: October 2010

Keywords provided by University Hospital, Caen:
TKR
Ultrasonography
asymptomatic deep venous thrombosis
extended duration prophylaxis
short duration prophylaxis

Additional relevant MeSH terms:
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases