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Completed

NCT Number: NCT00362492

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

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.

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Key information

Conditions

Thromboembolism Arthroplasty Replacement, Knee Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

46 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Alençon, Alençon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilateral ultrasound examination 7+/- 2 after surgery

Procedure

Primary outcomes

  1. Thromboembolism occuring between day 7-35 ;

  2. Major bleeding occuring between day 7-35 ;

  3. LMWH induced thrombopenia

  4. All cause mortality

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

9-10 Days Versus Prolonged Thromboprophylaxis in Patients Without Evidence of Ultrasound Proximal Thromboembolism After Total Knee Joint Replacement: a Randomized Controlled Trial

Important dates

Study start
2004
Study completion
2007
First posted
Aug 10, 2006
Registry last updated
Oct 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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