ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00358735
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : October 21, 2014
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
Medical Compression Systems

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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis of Lower Limb Pulmonary Embolism (PE) Bleeding Device: ActiveCare CECT device Drug: Enoxaparin Not Applicable

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  (Clinical Trial)
Actual Enrollment : 411 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty (THA): Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)
Study Start Date : June 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Heparin

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 Name: Lovenox




Primary Outcome Measures :
  1. Events of Deep Vein Thrombosis (DVT) [ Time Frame: 10-12 days post-op; and from day of surgery and up to 3 months if symptomatic ]

    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


  2. Clinical PE (Pulmonary Embolism) Events [ Time Frame: Day of surgery and up to 3 months ]
    Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT


Secondary Outcome Measures :
  1. Major Bleeding Complication [ Time Frame: Up to 30 days ]
    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.

  2. OutPatient Patients' Compliance [ Time Frame: 10-12 days post-op ]

    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.


  3. Serious Adverse Events [ Time Frame: SAE data were collected Up to 3 months post-op ]

    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


  4. In-Patients' Compliance [ Time Frame: Surgery till discharge ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358735


Locations
United States, California
Scripps Clinic
La Jolla, California, United States, 92037
Empire Orthopedic Center
Loma Linda, California, United States, 92324
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Indiana
The center for hip and knee surgery
Mooresville, Indiana, United States, 46158
United States, Maryland
Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
The Center Orthopedic & Neurosurgical Care &Research
Bend, Oregon, United States, 97701
Sponsors and Collaborators
Medical Compression Systems
Investigators
Principal Investigator: Clifford W Colwell, M.D Scripps Clinic

Publications of Results:
Responsible Party: Medical Compression Systems
ClinicalTrials.gov Identifier: NCT00358735     History of Changes
Other Study ID Numbers: MedicalCS06CC001
First Posted: August 1, 2006    Key Record Dates
Results First Posted: October 21, 2014
Last Update Posted: October 30, 2014
Last Verified: October 2014

Keywords provided by Medical Compression Systems:
SAFE
CECT
SFT
ActiveCare
ActiveCare+SFT
Deep Vein Thrombosis prevention
Total Hip Replacement
Total Hip Arthroplasty
Low Molecular Weight Heparin
MCS

Additional relevant MeSH terms:
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action