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

Phase 4

Completed

• Conditions: Thromboembolism; Arthroplasty Replacement, Knee

• Registration Number: NCT00362492
• Lead Sponsor: University Hospital, Caen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2006-08-09
• Study First Submitted QC: 2006-08-09
• Study First Posted: 2006-08-10
• Study Completion: 2007-06
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-27
• Last Update Posted: 2010-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 850

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Thromboembolism occuring between day 7-35 ;
Major bleeding occuring between day 7-35 ;
LMWH induced thrombopenia
All cause mortality

Trial Locations

Locations (17)

Clinique du Cèdre; 🇫🇷 Bois-Guillaume, France

Hospital Val D'ariège; 🇫🇷 Foix, France

Hospital University Angers; 🇫🇷 Angers, France

Hospital La Roche sur Yon; 🇫🇷 La Roche sur Yon, France

Clinique St Marie; 🇫🇷 Chalons sur Saone, France

Caen University hospital; 🇫🇷 Caen, France

Hospital Alençon; 🇫🇷 Alençon, France

Hospital University Lille; 🇫🇷 Lille, France

Mignot Hospital; 🇫🇷 Le Chesnay, France

Polyclinique de Riaumont; 🇫🇷 Lievin, France

Hospital Nord Mayenne; 🇫🇷 Mayenne, France

Montluçon Hospital; 🇫🇷 Montluçon, France

Poitiers University Hospital; 🇫🇷 Poitiers, France

Reims University Hospital; 🇫🇷 Reims, France

Clinique St André; 🇫🇷 Reims, France

Clinique St Jean Languedoc; 🇫🇷 Toulouse, France

Clinique St Jean; 🇫🇷 Roubaix, France