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

This study has been completed.

First Received: August 9, 2006 Last Updated: October 16, 2008 History of Changes

Sponsored by:	University Hospital, Caen
Information provided by:	University Hospital, Caen
ClinicalTrials.gov Identifier:	NCT00362492

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Surgery Ultrasound

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362492

Locations

France
Caen University hospital
Caen, France, 14033
Clinique du Cèdre
Bois-Guillaume, France, 76230
Polyclinique de Riaumont
LIEVIN, France, 62800
Poitiers University Hospital
Poitiers, France, 86021
Montluçon Hospital
Montluçon, France, 03100
Reims University Hospital
Reims, France, 51092
Mignot Hospital
Le Chesnay, France, 78150
Hospital La Roche sur Yon
La Roche sur Yon, France, 85295
Clinique St Marie
Chalons sur Saone, France, 71100
Hospital University Lille
Lille, France, 59037
Hospital Alençon
Alençon, France, 61014
Hospital Val D'ariège
Foix, France, 0941
Clinique St André
Reims, France, 51100
Hospital Nord Mayenne
Mayenne, France
Clinique St Jean Languedoc
Toulouse, France, 31077
Hospital University Angers
Angers, France
Clinique St Jean
Roubaix, France, 59100

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

No publications provided

Study ID Numbers:	PHRC-Prothege
Study First Received:	August 9, 2006
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00362492 History of Changes
Health Authority:	France: Health Ministry

Keywords provided by University Hospital, Caen:

TKR
Ultrasonography
asymptomatic deep venous thrombosis
extended duration prophylaxis
short duration prophylaxis

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases

Venous Thrombosis
Thromboembolism
Thrombosis

Additional relevant MeSH terms:

Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Thromboembolism

ClinicalTrials.gov processed this record on September 02, 2009