Clinical trial NCT00358735: Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Vein Thrombosis of Lower Limb
Pulmonary Embolism (PE)
Bleeding
Keywords: SAFE
CECT
SFT
ActiveCare
ActiveCare+SFT
Deep Vein Thrombosis prevention
Total Hip Replacement
Total Hip Arthroplasty
Low Molecular Weight Heparin
MCS
Lead sponsor: Medical Compression Systems
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 comparison with LMWH.

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 \[81 mg\]).

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.

Primary outcomes:
measure: Events of Deep Vein Thrombosis (DVT)
timeFrame: 10-12 days post-op; and from day of surgery and up to 3 months if symptomatic
measure: Clinical PE (Pulmonary Embolism) Events
timeFrame: Day of surgery and up to 3 months
Secondary outcomes:
measure: Major Bleeding Complication
timeFrame: Up to 30 days
measure: OutPatient Patients' Compliance
timeFrame: 10-12 days post-op
measure: Serious Adverse Events
timeFrame: SAE data were collected Up to 3 months post-op
measure: In-Patients' Compliance
timeFrame: Surgery till discharge
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Loma Linda
country: United States
facility: Empire Orthopedic Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Mooresville
country: United States
facility: The center for hip and knee surgery
state: Indiana
city: Baltimore
country: United States
facility: Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Bend
country: United States
facility: The Center Orthopedic & Neurosurgical Care &Research
state: Oregon
Study officials:
affiliation: Scripps Clinic
name: Clifford W Colwell, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colwell CW Jr, Froimson MI, Mont MA, Ritter MA, Trousdale RT, Buehler KC, Spitzer A, Donaldson TK, Padgett DE. Thrombosis prevention after total hip arthroplasty: a prospective, randomized trial comparing a mobile compression device with low-molecular-weight heparin. J Bone Joint Surg Am. 2010 Mar;92(3):527-35. doi: 10.2106/JBJS.I.00047.