Overview
Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)
Status:
Completed
Completed
Trial end date:
2008-12-01
2008-12-01
Target enrollment:
0
0
Participant gender:
All
All
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 comparison with LMWH.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Medical Compression SystemsTreatments:
Calcium heparin
Dalteparin
Enoxaparin
Heparin
Heparin, Low-Molecular-Weight
Criteria
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.