Deep Vein Thrombosis (DVT) Prevention in Total Hip Replacement: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH) (SAFE)
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Purpose
Evaluation of the safety and effectiveness of ActiveCare+SFT 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.
| Condition | Intervention |
|---|---|
|
Major Bleeding Venous Thrombosis (DVT) Pulmonary Embolism (PE) |
Device: ActiveCare+SFT Drug: Lovenox |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Deep Vein Thrombosis (DVT) Prevention in Total Hip Replacement: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH) |
- bleeding complications [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]Note: The study was powered for safety.
- DVT [ Time Frame: 10-12 days postoperative (duplex ultrasound). Clinical DVT were objectively assessed up to 3 months ] [ Designated as safety issue: No ]
- PE [ Time Frame: Clinical PE were objectively assessed up to 3 months (Spiral CT) ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: At discharge ] [ Designated as safety issue: Yes ]
- Patient's compliance (CECT group). [ Time Frame: End of prophylaxis (10-12 days) ] [ Designated as safety issue: No ]
| Enrollment: | 410 |
| Study Start Date: | June 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CECT group
ActiveCare+SFT system (+/- 81 mg/day aspirin)
|
Device: ActiveCare+SFT |
|
Active Comparator: Enoxaparin
30mg BID up to discharge and 40mg QD post-discharge, up to 10 days
|
Drug: Lovenox |
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| 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 |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00358735 History of Changes |
| Other Study ID Numbers: | MedicalCS06CC001 |
| Study First Received: | July 30, 2006 |
| Last Updated: | March 25, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Medical Compression Systems:
|
SAFE CECT SFT ActiveCare ActiveCare+SFT |
DVT prevention THR THA LMWH MCS |
Additional relevant MeSH terms:
|
Embolism Hemorrhage Pulmonary Embolism Thrombosis Venous Thrombosis Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Pathologic Processes Lung Diseases Respiratory Tract Diseases |
Thromboembolism Heparin, Low-Molecular-Weight Dalteparin Enoxaparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013