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

Study Overview
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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.

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]).

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

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

Intervention / Treatment
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* Device: ActiveCare CECT device
* Drug: Enoxaparin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ActiveCare CECT<br>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. | Device: ActiveCare CECT device<br>* 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.<br>* Other names: ActiveCare+SFT;|
| Active Comparator: LMWH (Enoxaparin)<br>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. | Drug: Enoxaparin<br>* 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.<br>* Other names: Lovenox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Events of Deep Vein Thrombosis (DVT) | 10-12 days post-op: All of the patients underwent Routine bilateral compression Doppler. Day of surgery and up to 3 months post-op: Suspected clinical signs and symptoms DVT events were confirmed by standard diagnostic objective methods | 10-12 days post-op; and from day of surgery and up to 3 months if symptomatic | 
| Clinical PE (Pulmonary Embolism) Events | Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT | Day of surgery and up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Bleeding Complication | Major bleeding is defined as bleeding that requires rehospitalization or prolonged hospitalization, requires any intervention such as surgery or hematoma aspiration to prevent permanent impairment or damage, endangered critical organs, is life threatening or causes death. Data collected included bleeding index, a decrease in hemoglobin greater than/equal to 20 g/L, and number of units of blood transfused. | Up to 30 days | 
| OutPatient Patients' Compliance | Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer. The compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of home treatment (for the entire arm/group). The compliance is expressed as percentages. | 10-12 days post-op | 
| Serious Adverse Events | Serious Adverse Events (SAE) is any event that prolongs hospitalization or requires re-hospitalization, that requires intervention to prevent permanent impairment or damage, that causes permanent disability, or that is life threatening. SAE did not include Venous thrombolembolism (VTE) events (DVT and PE) and Major bleeding complications as these are outcome measures | SAE data were collected Up to 3 months post-op | 
| In-Patients' Compliance | Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer. The compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of treatment at hospital (for the entire arm/group). The compliance is expressed as percentages. | Surgery till discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SFT, SAFE, CECT, ActiveCare, ActiveCare+SFT, Deep Vein Thrombosis prevention, Total Hip Replacement, Total Hip Arthroplasty, Low Molecular Weight Heparin, MCS