Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Medical Compression Systems |
---|---|
Information provided by: | Medical Compression Systems |
ClinicalTrials.gov Identifier: | NCT00358735 |
Evaluation of the effectiveness of ActiveCare CECT device +/- baby aspirin (81 mg QD) for lowering the potential risk of DVT during and after THA surgery in comparison with LMWH.
Condition | Intervention |
---|---|
Venous Thrombosis Pulmonary Embolism |
Device: ActiveCare+SFT |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Deep Vein Thrombosis (DVT) Prevention in Total Hip Replacement: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
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.
United States, California | |
Scripps Clinic | |
La Jolla, California, United States, 92037 | |
Empire Orthopedic Center | |
Loma Linda, California, United States, 92324 | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
United States, Indiana | |
The center for hip and knee surgery | |
Mooresville, Indiana, United States, 46158 | |
United States, Maryland | |
Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore | |
Baltimore, Maryland, United States, 21215 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55902 | |
United States, New York | |
Hospital for Special Surgery | |
New York, New York, United States, 10021 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Oregon | |
The Center Orthopedic & Neurosurgical Care &Research | |
Bend, Oregon, United States, 97701 |
Principal Investigator: | Clifford W Colwell, M.D | Scripps Clinic |
Study ID Numbers: | MedicalCS06CC001 |
Study First Received: | July 30, 2006 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00358735 |
Health Authority: | United States: Institutional Review Board |
CECT DVT prevention THR LMWH |
Body Weight Embolism and Thrombosis Pulmonary Embolism Respiratory Tract Diseases Embolism Heparin, Low-Molecular-Weight |
Lung Diseases Vascular Diseases Venous Thrombosis Heparin Thrombosis Calcium heparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |