Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH) (SAFE)
Deep Vein Thrombosis of Lower Limb, Pulmonary Embolism (PE), Bleeding
About this trial
This is an interventional prevention trial for Deep Vein Thrombosis of Lower Limb focused on measuring SAFE, CECT, SFT, ActiveCare, ActiveCare+SFT, Deep Vein Thrombosis prevention, Total Hip Replacement, Total Hip Arthroplasty, Low Molecular Weight Heparin, MCS
Eligibility 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.
Sites / Locations
- Scripps Clinic
- Empire Orthopedic Center
- Cedars-Sinai Medical Center
- The center for hip and knee surgery
- Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore
- Mayo Clinic
- Hospital for Special Surgery
- Cleveland Clinic
- The Center Orthopedic & Neurosurgical Care &Research
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
ActiveCare CECT
LMWH (Enoxaparin)
The ActiveCare CECT device is a mobile compression device used to prevent venous thromboembolic events, used after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery.
Enoxaparin (LMWH) will be used, following a protocol that is considered a standard of care for this patient population. 40mg QD for the remainder of the 10 days.