Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis

Completed · Phase 4

Conditions studied: Thrombosis

In brief

The objective of this trial is to demonstrate the clinical utility of fixed-dose SC Desirudin for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.

Key facts

Study ID

NCT00913133

Run by

Canyon Pharmaceuticals, Inc.

People needed

516

Starts

2010-03-01

Expected to finish

2011-06-01

Last updated by the study team

2013-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide written informed consent before initiation of any study related procedures.
• Be at least 18 years of age.
• Patients requiring anticoagulation for the prophylaxis of thrombosis.
• In the opinion of the Investigator, an alternative to heparin-based anticoagulant therapies is desirable.

You may not qualify if…

• Confirmed pregnancy (if woman of child-bearing potential) (urine or serum pregnancy test).
• Intracranial neoplasm, arteriovenous malformation or aneurysm.
• 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.
• Known allergy to desirudin or hirudin-derived drugs, or known sensitivity to any component of the product
• 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).
• Refusal to undergo blood transfusion should it become necessary
• Active bleeding or irreversible coagulation abnormality.
• Uncontrolled hypertension defined as a blood pressure > or equal to 180/110 mmHg.
• Patients requiring anticoagulation for left-ventricular assist device, intra-aortic balloon pump, veno-venous ultra filtration or ECMO.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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