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

University Hospital, Caen850 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

850

Conditions

Thromboembolism Arthroplasty Replacement, Knee

Interventions

Bilateral ultrasound examination 7+/- 2 after surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 46 Years

Medical Language ↔ Plain English

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

Locations (17)

Hospital Alençon

Alençon, France

Hospital University Angers

Angers, France

Clinique du Cèdre

Bois-Guillaume, France

Outcomes

Primary Outcomes

Thromboembolism occuring between day 7-35 ;

Major bleeding occuring between day 7-35 ;

LMWH induced thrombopenia

All cause mortality

Data from ClinicalTrials.gov

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