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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical Compression Systems
ClinicalTrials.gov Identifier:
NCT00358735
First received: July 30, 2006
Last updated: April 14, 2014
Last verified: February 2010
  Purpose

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 Intervention
Deep Vein Thrombosis of Lower Limb
Pulmonary Embolism (PE)
Bleeding
Device: ActiveCare CECT device
Drug: Enoxaparin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by Medical Compression Systems:

Primary Outcome Measures:
  • Deep vein thrombosis (DVT) [ Time Frame: 10-12 days post-op; up to 3 months post-op ] [ Designated as safety issue: No ]
    Patients will be examined for clinical signs and symptoms of Deep Vein thrombosis (DVT). Suspected clinical DVT events during the followup period will be confirmed by standard diagnostic objective methods.

  • Pulmonary Embolism (PE) [ Time Frame: up to 3 months post-op ] [ Designated as safety issue: No ]
    Suspected clinical PE events during this followup period will be confirmed by standard objective diagnostic methods.


Secondary Outcome Measures:
  • Bleeding [ Time Frame: Up to 3 months post-op ] [ Designated as safety issue: Yes ]
    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. Minor bleeding is any bleeding not considered major bleeding (e.g., increased wound drainage or drop in hemoglobin not requiring transfusion or prolonged hospitalization). Data collected will include bleeding index, a decrease in hemoglobin greater than/equal to 20 g/L, and number of units of blood transfused.

  • Adverse events [ Time Frame: At discharge; Up to 3 months post-op ] [ Designated as safety issue: Yes ]
    An adverse event is any undesirable experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a patient that appears or worsens during a clinical study. A serious adverse event (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.

  • Patient's compliance (CECT group). [ Time Frame: 10-12 days post-op ] [ Designated as safety issue: No ]
    Total pneumatic usage time and patient's compliance will be recorded using the device internal timer.


Enrollment: 410
Study Start Date: June 2006
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
Responsible Party: Medical Compression Systems
ClinicalTrials.gov Identifier: NCT00358735     History of Changes
Other Study ID Numbers: MedicalCS06CC001
Study First Received: July 30, 2006
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

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:
Venous Thrombosis
Pulmonary Embolism
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Embolism
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 16, 2014