Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)

Condition(s) targeted: Deep Vein Thrombosis of Lower Limb; Pulmonary Embolism (PE); Bleeding

Intervention: ActiveCare CECT device (Device); Enoxaparin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Medical Compression Systems

Official(s) and/or principal investigator(s):
Clifford W Colwell, M.D, Principal Investigator, Affiliation: Scripps Clinic

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.

Official title: Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty (THA): Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Events of Deep Vein Thrombosis (DVT)

Clinical PE (Pulmonary Embolism) Events

Secondary outcome:

Major Bleeding Complication

OutPatient Patients' Compliance

Serious Adverse Events

In-Patients' Compliance

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 [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]).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Scripps Clinic, La Jolla, California 92037, United States

Empire Orthopedic Center, Loma Linda, California 92324, United States

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States

The center for hip and knee surgery, Mooresville, Indiana 46158, United States

Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore, Baltimore, Maryland 21215, United States

Mayo Clinic, Rochester, Minnesota 55902, United States

Hospital for Special Surgery, New York, New York 10021, United States

Cleveland Clinic, Cleveland, Ohio 44195, United States

The Center Orthopedic & Neurosurgical Care &Research, Bend, Oregon 97701, United States

Summary and brochure of the S.A.F.E study

Video Spotlight from JBJS online journal

Starting date: June 2006
Last updated: October 21, 2014