|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Medical Compression Systems |
| Information provided by: | Medical Compression Systems |
| ClinicalTrials.gov Identifier: | NCT00358735 |
Purpose
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 |
| MedlinePlus related topics: | Pulmonary Embolism Thrombophlebitis |
| ChemIDplus related topics: | Heparin |
| 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) |
Eligibility
| 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.
Contacts and Locations| Contact: Jonathan Koltin | 972 4 6266630 ext 110 | jonathan@mcsmed.com |
| United States, California | |||||
| Scripps Clinic | Recruiting | ||||
| La Jolla, California, United States, 92037 | |||||
| Contact: Tricia L Chaffee, R.N 858-332-0131 Chaffee.Tricia@scrippshealth.org | |||||
| Principal Investigator: Clifford W Colwell, M.D | |||||
| Empire Orthopedic Center | Recruiting | ||||
| Loma Linda, California, United States, 92324 | |||||
| Contact: Janelle Warren, MS, FNP 909-882-5867 landrusak@empireortho.org | |||||
| Principal Investigator: Dr. Thomas K. Donaldson, M.D | |||||
| Cedars-Sinai Medical Center | Recruiting | ||||
| Los Angeles, California, United States, 90048 | |||||
| Contact: Beth Habelow, MSPT 310-423-9211 Habelowb@cshs.org | |||||
| Principal Investigator: Andrew Spitzer, MD | |||||
| United States, Indiana | |||||
| The center for hip and knee surgery | Recruiting | ||||
| Mooresville, Indiana, United States, 46158 | |||||
| Contact: Amy Robertson, RN 317-831-2273 arobertsonrn@yahoo.com | |||||
| Principal Investigator: Merrill A Ritter, M.D | |||||
| United States, Maryland | |||||
| Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore | Recruiting | ||||
| Baltimore, Maryland, United States, 21215 | |||||
| Contact: Rivka . Gutterman, RN,BSN 410-601-9969 rgutterm@lifebridgehealth.org | |||||
| Principal Investigator: Dr. Michael Mont, M.D | |||||
| United States, Minnesota | |||||
| Mayo Clinic | Recruiting | ||||
| Rochester, Minnesota, United States, 55902 | |||||
| Contact: Charlene Blanchard 507-284-1175 blanchard.charlene@mayo.edu | |||||
| Principal Investigator: Robert T Trousdale, MD | |||||
| United States, New York | |||||
| Hospital for Special Surgery | Recruiting | ||||
| New York, New York, United States, 10021 | |||||
| Contact: Kristin L Foote 212-606-1484 Footek@HSS.edu | |||||
| Principal Investigator: Douglas E Padgett, MD | |||||
| United States, Ohio | |||||
| Cleveland Clinic | Recruiting | ||||
| Cleveland, Ohio, United States, 44195 | |||||
| Contact: Lisa Hegemier, MA, PA-C 216-444-5935 HEGEML@ccf.org | |||||
| Principal Investigator: Mark Froimson, M.D. | |||||
| United States, Oregon | |||||
| The Center Orthopedic & Neurosurgical Care &Research | Recruiting | ||||
| Bend, Oregon, United States, 97701 | |||||
| Contact: Debora Rogers, ANP 541-382-3344 drogers@neuro-ortho.com | |||||
| Principal Investigator: Knute Buehler, M.D. | |||||
| Medical Compression Systems |
| Principal Investigator: | Clifford W Colwell, M.D | Scripps Clinic |
More Information
| Study ID Numbers: | MedicalCS06CC001 |
| First Received: | July 30, 2006 |
| Last Updated: | October 23, 2007 |
| ClinicalTrials.gov Identifier: | NCT00358735 |
| Health Authority: | United States: Institutional Review Board |
|
|
|
|
|