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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 has been completed.
Study NCT00358735   Information provided by Medical Compression Systems
First Received: July 30, 2006   Last Updated: October 6, 2008   History of Changes

July 30, 2006
October 6, 2008
June 2006
 
  • DVT
  • PE
Same as current
Complete list of historical versions of study NCT00358735 on ClinicalTrials.gov Archive Site
  • adverse events at discharge
  • bleeding complications
  • patient's compliance (CECT).
  • adverse events at discharge
  • bleeding complications
  • patient’s compliance (CECT).
 
Deep Vein Thrombosis (DVT) Prevention in Total Hip Replacement: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)
Deep Vein Thrombosis (DVT) Prevention in Total Hip Replacement: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)

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.

 
 
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
  • Venous Thrombosis
  • Pulmonary Embolism
Device: ActiveCare+SFT
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00358735
 
MedicalCS06CC001
Medical Compression Systems
 
Principal Investigator: Clifford W Colwell, M.D Scripps Clinic
Medical Compression Systems
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP