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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

411 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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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 \[81 mg\]).

Conditions

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Deep Vein Thrombosis of Lower Limb Pulmonary Embolism (PE) Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ActiveCare CECT

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.

Group Type EXPERIMENTAL

ActiveCare CECT device

Intervention Type DEVICE

Patients will be treated with the ActiveCare+ CECT device starting after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery. Baby aspirin (81 mg) QD can be added (depending on surgeon preference) 12-24 hours after surgery. Post discharge prophylaxis is the same for the remainder of the 10-12 days. Patients will wear the device to the duplex ultrasound when it will be discontinued by nurse.

LMWH (Enoxaparin)

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.

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

Patients will be treated with Enoxaparin (Lovenox) for a total of 10 days beginning with 30mg BID starting 12-24 hours after surgery and continued until hospital discharge. Post discharge prophylaxis will be Enoxaparin 40mg QD for the remainder of the 10 days.

Interventions

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ActiveCare CECT device

Patients will be treated with the ActiveCare+ CECT device starting after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery. Baby aspirin (81 mg) QD can be added (depending on surgeon preference) 12-24 hours after surgery. Post discharge prophylaxis is the same for the remainder of the 10-12 days. Patients will wear the device to the duplex ultrasound when it will be discontinued by nurse.

Intervention Type DEVICE

Enoxaparin

Patients will be treated with Enoxaparin (Lovenox) for a total of 10 days beginning with 30mg BID starting 12-24 hours after surgery and continued until hospital discharge. Post discharge prophylaxis will be Enoxaparin 40mg QD for the remainder of the 10 days.

Intervention Type DRUG

Other Intervention Names

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ActiveCare+ ActiveCare DVT ActiveCare+SFT Lovenox

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No