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

NCT ID: NCT00362492

Last Updated: 2010-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-06-30

Brief Summary

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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

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Conditions

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Thromboembolism Arthroplasty Replacement, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Bilateral ultrasound examination 7+/- 2 after surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* First total knee joint replacement
* Signed informed consent


* History of venous thromboembolism/major bleeding/Heparin induced thrombopenia
* Active cancer
* Long-term anticoagulation
Minimum Eligible Age

46 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Principal Investigators

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Marie-Thérèse Barrellier, MD

Role: PRINCIPAL_INVESTIGATOR

Côte de Nacre University hospital

Claude Vielpeau, MD

Role: STUDY_CHAIR

Côte de Nacre University hospital

Locations

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Hospital Alençon

Alençon, , France

Site Status

Hospital University Angers

Angers, , France

Site Status

Clinique du Cèdre

Bois-Guillaume, , France

Site Status

Caen University hospital

Caen, , France

Site Status

Clinique St Marie

Chalon-sur-Saône, , France

Site Status

Hospital Val D'ariège

Foix, , France

Site Status

Hospital La Roche sur Yon

La Roche-sur-Yon, , France

Site Status

Mignot Hospital

Le Chesnay, , France

Site Status

Polyclinique de Riaumont

Liévin, , France

Site Status

Hospital University Lille

Lille, , France

Site Status

Hospital Nord Mayenne

Mayenne, , France

Site Status

Montluçon Hospital

Montluçon, , France

Site Status

Poitiers University Hospital

Poitiers, , France

Site Status

Reims University Hospital

Reims, , France

Site Status

Clinique St André

Reims, , France

Site Status

Clinique St Jean

Roubaix, , France

Site Status

Clinique St Jean Languedoc

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 20797774 (View on PubMed)

Other Identifiers

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PHRC-Prothege

Identifier Type: -

Identifier Source: org_study_id