Bleeding Clinical Trial
Official title:
Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty (THA): Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)
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.
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 [IPC]) and pharmacological (anticoagulant). Both are effective;
however each carries its own advantages and disadvantages.
The purpose of this study is to compare in total hip arthroplasty (THA) patients the safety
and effectiveness of the mobile ActiveCare CECT based prophylaxis protocol and compare it
with LMWH standard of care protocol for this patient population.
The protocol is based upon the CECT system as the primary DVT prophylaxis method (with or
without the addition of low dose baby aspirin [81 mg]).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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