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

Caen University Hospital

Status and phase: Completed; Phase 4

Conditions: Thromboembolism; Arthroplasty Replacement, Knee

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00362492

PHRC-Prothege

Details and patient eligibility

About

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.

Enrollment: 850 estimated patients

Sex: All

Ages: 46+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)