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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT00362492
First received: August 9, 2006
Last updated: October 27, 2010
Last verified: October 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   46 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 9, 2006
Last Updated: October 27, 2010
Health Authority: France: Health Ministry

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
Thrombosis

ClinicalTrials.gov processed this record on September 18, 2014