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

Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362492
• Other study ID #: PHRC-Prothege
• Status: Completed
• Phase: Phase 4
• First received: August 9, 2006
• Last updated: October 27, 2010
• Start date: June 2004
• Est. completion date: June 2007

Study information

• Verified date: October 2010
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Health Ministry
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 46 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthroplasty Replacement, Knee
• Thromboembolism

Intervention

Procedure:
• Bilateral ultrasound examination 7+/- 2 after surgery

Locations

Country	Name	City	State
France	Hospital Alençon	Alençon
France	Hospital University Angers	Angers
France	Clinique du Cèdre	Bois-Guillaume
France	Caen University hospital	Caen
France	Clinique St Marie	Chalons sur Saone
France	Hospital Val D'ariège	Foix
France	Hospital La Roche sur Yon	La Roche sur Yon
France	Mignot Hospital	Le Chesnay
France	Polyclinique de Riaumont	Lievin
France	Hospital University Lille	Lille
France	Hospital Nord Mayenne	Mayenne
France	Montluçon Hospital	Montluçon
France	Poitiers University Hospital	Poitiers
France	Clinique St André	Reims
France	Reims University Hospital	Reims
France	Clinique St Jean	Roubaix
France	Clinique St Jean Languedoc	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (1)

Barrellier MT, Lebel B, Parienti JJ, Mismetti P, Dutheil JJ, Vielpeau C; PROTHEGE study group; GETHCAM study group. Short versus extended thromboprophylaxis after total knee arthroplasty: a randomized comparison. Thromb Res. 2010 Oct;126(4):e298-304. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thromboembolism occuring between day 7-35 ;
Primary	Major bleeding occuring between day 7-35 ;
Primary	LMWH induced thrombopenia
Primary	All cause mortality