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

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

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.

Study Overview

• Status: Completed
• Conditions: Bleeding; Pulmonary Embolism (PE); Deep Vein Thrombosis of Lower Limb
• Intervention / Treatment: Device: ActiveCare CECT device; Drug: Enoxaparin

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]).

• Study Type: Interventional
• Enrollment (Actual): 411
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Clinic
    • Loma Linda, California, United States, 92324
      • Empire Orthopedic Center
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Indiana
    • Mooresville, Indiana, United States, 46158
      • The center for hip and knee surgery
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oregon
    • Bend, Oregon, United States, 97701
      • The Center Orthopedic & Neurosurgical Care &Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: ActiveCare+; ActiveCare DVT; ActiveCare+SFT
Active Comparator: 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.	Drug: 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.; Other Names: Lovenox

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical Compression Systems
• Investigators: Principal Investigator: Clifford W Colwell, M.D, Scripps Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: July 30, 2006
• First Submitted That Met QC Criteria: July 31, 2006
• First Posted (Estimate): August 1, 2006

Study Record Updates

• Last Update Posted (Estimate): October 30, 2014
• Last Update Submitted That Met QC Criteria: October 21, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: MCS; Total Hip Arthroplasty; Low Molecular Weight Heparin; Total Hip Replacement; CECT; SAFE; SFT; ActiveCare; ActiveCare+SFT; Deep Vein Thrombosis prevention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Pulmonary Embolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin
• Other Study ID Numbers: MedicalCS06CC001