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Deep Vein Thrombosis (DVT) Prevention in Total Hip Replacement: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH) (SAFE)
This study has been completed.

First Received on July 30, 2006.   Last Updated on March 25, 2010   History of Changes
Sponsor: Medical Compression Systems
Information provided by: Medical Compression Systems
ClinicalTrials.gov Identifier: NCT00358735
  Purpose

Evaluation of the safety and effectiveness of ActiveCare+SFT 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
Major Bleeding
Venous Thrombosis (DVT)
Pulmonary Embolism (PE)
Device: ActiveCare+SFT
Drug: Lovenox

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 Replacement: 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:
  • bleeding complications [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]
    Note: The study was powered for safety.


Secondary Outcome Measures:
  • DVT [ Time Frame: 10-12 days postoperative (duplex ultrasound). Clinical DVT were objectively assessed up to 3 months ] [ Designated as safety issue: No ]
  • PE [ Time Frame: Clinical PE were objectively assessed up to 3 months (Spiral CT) ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: At discharge ] [ Designated as safety issue: Yes ]
  • Patient's compliance (CECT group). [ Time Frame: End of prophylaxis (10-12 days) ] [ Designated as safety issue: No ]

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: CECT group
ActiveCare+SFT system (+/- 81 mg/day aspirin)
Device: ActiveCare+SFT
Active Comparator: Enoxaparin
30mg BID up to discharge and 40mg QD post-discharge, up to 10 days
Drug: Lovenox

  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
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:
ClinicalTrials.gov Identifier: NCT00358735     History of Changes
Other Study ID Numbers: MedicalCS06CC001
Study First Received: July 30, 2006
Last Updated: March 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Medical Compression Systems:
SAFE
CECT
SFT
ActiveCare
ActiveCare+SFT
DVT prevention
THR
THA
LMWH
MCS

Additional relevant MeSH terms:
Embolism
Hemorrhage
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Heparin, Low-Molecular-Weight
Dalteparin
Enoxaparin
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 February 12, 2012