Clinical trial NCT00362492: Safety Study of Stopping Thromboprophylaxis Based on Ultrasound Results After Total Knee Replacement
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thromboembolism
Arthroplasty Replacement, Knee
Keywords: TKR
Ultrasonography
asymptomatic deep venous thrombosis
extended duration prophylaxis
short duration prophylaxis
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2006-08-10
Enrollment: 850
Sex: ALL
Minimum age (years): 46
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Thromboembolism occuring between day 7-35 ;
measure: Major bleeding occuring between day 7-35 ;
measure: LMWH induced thrombopenia
measure: All cause mortality
Secondary outcomes:
Other outcomes:
Locations:
city: Alençon
country: France
facility: Hospital Alençon
city: Angers
country: France
facility: Hospital University Angers
city: Bois-Guillaume
country: France
facility: Clinique du Cèdre
city: Caen
country: France
facility: Caen University hospital
city: Chalons sur Saone
country: France
facility: Clinique St Marie
city: Foix
country: France
facility: Hospital Val D'ariège
city: La Roche sur Yon
country: France
facility: Hospital La Roche sur Yon
city: Le Chesnay
country: France
facility: Mignot Hospital
city: Lievin
country: France
facility: Polyclinique de Riaumont
city: Lille
country: France
facility: Hospital University Lille
city: Mayenne
country: France
facility: Hospital Nord Mayenne
city: Montluçon
country: France
facility: Montluçon Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Reims
country: France
facility: Reims University Hospital
city: Reims
country: France
facility: Clinique St André
city: Roubaix
country: France
facility: Clinique St Jean
city: Toulouse
country: France
facility: Clinique St Jean Languedoc
Study officials:
affiliation: Côte de Nacre University hospital
name: Marie-Thérèse Barrellier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Côte de Nacre University hospital
name: Claude Vielpeau, MD
role: STUDY_CHAIR
References:
citation: 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: 10.1016/j.thromres.2010.07.018. Epub 2010 Aug 24.