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

This study is currently recruiting participants.
Verified by Medical Compression Systems, October 2007

Sponsored by: Medical Compression Systems
Information provided by: Medical Compression Systems
ClinicalTrials.gov Identifier: NCT00358735
  Purpose

Evaluation of the effectiveness of ActiveCare CECT device +/- baby aspirin (81 mg QD) for lowering the potential risk of DVT during and after THA surgery in comparison with LMWH.


Condition Intervention
Venous Thrombosis
Pulmonary Embolism
Device: ActiveCare+SFT

MedlinePlus related topics:   Pulmonary Embolism   Thrombophlebitis  

ChemIDplus related topics:   Heparin  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Deep Vein Thrombosis (DVT) Prevention in Total Hip Replacement: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)

Further study details as provided by Medical Compression Systems:

Primary Outcome Measures:
  • DVT
  • PE

Secondary Outcome Measures:
  • adverse events at discharge
  • bleeding complications
  • patient's compliance (CECT).

Study Start Date:   June 2006

  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

Contacts
Contact: Jonathan Koltin     972 4 6266630 ext 110     jonathan@mcsmed.com    

Locations
United States, California
Scripps Clinic     Recruiting
      La Jolla, California, United States, 92037
      Contact: Tricia L Chaffee, R.N     858-332-0131     Chaffee.Tricia@scrippshealth.org    
      Principal Investigator: Clifford W Colwell, M.D            
Empire Orthopedic Center     Recruiting
      Loma Linda, California, United States, 92324
      Contact: Janelle Warren, MS, FNP     909-882-5867     landrusak@empireortho.org    
      Principal Investigator: Dr. Thomas K. Donaldson, M.D            
Cedars-Sinai Medical Center     Recruiting
      Los Angeles, California, United States, 90048
      Contact: Beth Habelow, MSPT     310-423-9211     Habelowb@cshs.org    
      Principal Investigator: Andrew Spitzer, MD            
United States, Indiana
The center for hip and knee surgery     Recruiting
      Mooresville, Indiana, United States, 46158
      Contact: Amy Robertson, RN     317-831-2273     arobertsonrn@yahoo.com    
      Principal Investigator: Merrill A Ritter, M.D            
United States, Maryland
Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore     Recruiting
      Baltimore, Maryland, United States, 21215
      Contact: Rivka . Gutterman, RN,BSN     410-601-9969     rgutterm@lifebridgehealth.org    
      Principal Investigator: Dr. Michael Mont, M.D            
United States, Minnesota
Mayo Clinic     Recruiting
      Rochester, Minnesota, United States, 55902
      Contact: Charlene Blanchard     507-284-1175     blanchard.charlene@mayo.edu    
      Principal Investigator: Robert T Trousdale, MD            
United States, New York
Hospital for Special Surgery     Recruiting
      New York, New York, United States, 10021
      Contact: Kristin L Foote     212-606-1484     Footek@HSS.edu    
      Principal Investigator: Douglas E Padgett, MD            
United States, Ohio
Cleveland Clinic     Recruiting
      Cleveland, Ohio, United States, 44195
      Contact: Lisa Hegemier, MA, PA-C     216-444-5935     HEGEML@ccf.org    
      Principal Investigator: Mark Froimson, M.D.            
United States, Oregon
The Center Orthopedic & Neurosurgical Care &Research     Recruiting
      Bend, Oregon, United States, 97701
      Contact: Debora Rogers, ANP     541-382-3344     drogers@neuro-ortho.com    
      Principal Investigator: Knute Buehler, M.D.            

Sponsors and Collaborators
Medical Compression Systems

Investigators
Principal Investigator:     Clifford W Colwell, M.D     Scripps Clinic    
  More Information

Study ID Numbers:   MedicalCS06CC001
First Received:   July 30, 2006
Last Updated:   October 23, 2007
ClinicalTrials.gov Identifier:   NCT00358735
Health Authority:   United States: Institutional Review Board

Keywords provided by Medical Compression Systems:
CECT  
DVT prevention  
THR  
LMWH  

Study placed in the following topic categories:
Body Weight
Embolism and Thrombosis
Pulmonary Embolism
Embolism
Heparin, Low-Molecular-Weight
Lung Diseases
Vascular Diseases
Venous Thrombosis
Heparin
Thrombosis
Calcium heparin

Additional relevant MeSH terms:
Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Respiratory Tract Diseases
Therapeutic Uses
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 15, 2008