Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)

Completed · Not applicable

Conditions studied: Deep Vein Thrombosis of Lower Limb, Pulmonary Embolism (PE), Bleeding

In brief

Evaluation of the safety and effectiveness of ActiveCare+ CECT device +/- baby dose aspirin (81 mg QD) for lowering the potential risk for bleeding and of DVT during and after THA surgery in comparison with LMWH.

Key facts

Study ID

NCT00358735

Run by

Medical Compression Systems

People needed

411

Starts

2006-06-01

Expected to finish

2008-12-01

Last updated by the study team

2014-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patient (Age >18). Patient intended to undergo elective primary unilateral THA surgery. Patient is able and willing to follow instructions of care after surgery. Patient is able and willing to sign the institution human subjects committee approved Informed Consent Form.

You may not qualify if…

• Patient who has a known coagulation disorder. Patient currently treated with anticoagulant medications. Patient with known thrombophilia Patient with current signs and symptoms of or history of DVT/PE. Patient who is uncooperative or unable to follow instructions. Patient currently suffering from a solid tumor malignancy. Patient with active peptic disease. Patient with known allergy to baby aspirin (81 mg) or enoxaparin. Patient with contraindication to use of the device including patients with leg gangrene, recent skin graft or medical situations where increase venous and lymphatic return is undesirable.Patient has major surgery procedure within 3 months prior to the study surgery, or patients with a major surgery procedure planning during the study period.Pregnant women.Patient who is participating in another clinical drug trial.

Where it is running

• Scripps Clinic — La Jolla, California, United States
• Empire Orthopedic Center — Loma Linda, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• The center for hip and knee surgery — Mooresville, Indiana, United States
• Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Hospital for Special Surgery — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The Center Orthopedic & Neurosurgical Care &Research — Bend, Oregon, United States

Full record on ClinicalTrials.gov

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