Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis
NCT ID: NCT00913133
Last Updated: 2013-01-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
516 participants
INTERVENTIONAL
2010-03-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Desirudin
desirudin 15 mg twice daily for a minimum of 5 days
Desirudin
Desirudin SC 15mg q12h
Interventions
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Desirudin
Desirudin SC 15mg q12h
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Be at least 18 years of age.
3. Patients requiring anticoagulation for the prophylaxis of thrombosis.
4. In the opinion of the Investigator, an alternative to heparin-based anticoagulant therapies is desirable.
Exclusion Criteria
2. Intracranial neoplasm, arteriovenous malformation or aneurysm.
3. Severe renal insufficiency (chronic or acute) with a GFR of \< or equal to 30 mL/min as determined by measured or estimated creatinine clearance using Cockroft-Gault method or by estimated GFR using the MDRD formula.
4. Known allergy to desirudin or hirudin-derived drugs, or known sensitivity to any component of the product
5. Participation in other clinical research studies involving the evaluation of other investigational or FDA-approved drugs or devices within 30 days of enrollment (participation in observational studies of FDA-approved products is acceptable).
6. Refusal to undergo blood transfusion should it become necessary
7. Active bleeding or irreversible coagulation abnormality.
8. Uncontrolled hypertension defined as a blood pressure \> or equal to 180/110 mmHg.
9. Patients requiring anticoagulation for left-ventricular assist device, intra-aortic balloon pump, veno-venous ultra filtration or ECMO.
10. Any other disease or condition which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial.
18 Years
ALL
No
Sponsors
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Canyon Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dawn Bell, PharmD
Role: STUDY_DIRECTOR
Canyon Pharmaceuticals, Inc.
Jerrold Levy, MD, FAHA
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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University of Colorado Health Science Center
Aurora, Colorado, United States
University of South Florida, Tampa General Hospital
Tampa, Florida, United States
Saint Joseph's Research Institute
Atlanta, Georgia, United States
Southeastern Center for Clinical Trials
Decatur, Georgia, United States
Provena St. Joseph's Medical Center
Joliet, Illinois, United States
Illinois Lung and Critical Care Institute
Peoria, Illinois, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
Overlook Hospital
Summit, New Jersey, United States
Weill Cornell Medical College
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Forsyth Regional Medical Center
Winston-Salem, North Carolina, United States
Forsyth Regional Medical Center
Winston-Salem, North Carolina, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Research Concepts, Memorial Hermann Healthcare System
Houston, Texas, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
Countries
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Other Identifiers
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DES-09-02
Identifier Type: -
Identifier Source: org_study_id
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