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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.
Information provided by Medical Compression Systems

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Descriptive Information Fields
Brief Title  Deep Vein Thrombosis (DVT) Prevention in Total Hip Replacement: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)
Official Title  Deep Vein Thrombosis (DVT) Prevention in Total Hip Replacement: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)
Brief Summary

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.

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  DVT
PE
Secondary Outcome Measure  adverse events at discharge
bleeding complications
patient's compliance (CECT).
Condition  Venous Thrombosis
Pulmonary Embolism
Intervention  Device: ActiveCare+SFT
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment 
Start Date  June 2006
Completion Date
Eligibility 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.

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Jonathan Koltin     972 4 6266630 ext 110     jonathan@mcsmed.com    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00358735
Organization ID MedicalCS06CC001
Secondary IDs ††
Study Sponsor  Medical Compression Systems
Collaborators ††
Investigators 
Principal Investigator:     Clifford W Colwell, M.D     Scripps Clinic    
Information Provided By Medical Compression Systems
Verification Date October 2007
First Received Date  July 30, 2006
Last Updated Date October 23, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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