Status:
COMPLETED
Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)
Lead Sponsor:
Medical Compression Systems
Conditions:
Deep Vein Thrombosis of Lower Limb
Pulmonary Embolism (PE)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 compariso...
Detailed Description
Patients undergoing total hip arthroplasty surgery are at particular risk for Thromboembolic disease. To date two prophylactic modalities are being used: mechanical (intermittent pneumatic compression...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
411 Patients enrolled
Trial Details
Trial ID
NCT00358735
Start Date
June 1 2006
End Date
December 1 2008
Last Update
October 30 2014
Active Locations (9)
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1
Scripps Clinic
La Jolla, California, United States, 92037
2
Empire Orthopedic Center
Loma Linda, California, United States, 92324
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
4
The center for hip and knee surgery
Mooresville, Indiana, United States, 46158