Status:
COMPLETED
Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis
Lead Sponsor:
Canyon Pharmaceuticals, Inc.
Conditions:
Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
Hospitalized patients who require DVT prophylaxis and who are not good candidates for heparin-based anti-coagulation were eligible.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
516 Patients enrolled
Trial Details
Trial ID
NCT00913133
Start Date
March 1 2010
End Date
June 1 2011
Last Update
January 10 2013
Active Locations (16)
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1
University of Colorado Health Science Center
Aurora, Colorado, United States, 80045
2
University of South Florida, Tampa General Hospital
Tampa, Florida, United States, 33606
3
Saint Joseph's Research Institute
Atlanta, Georgia, United States, 30342
4
Southeastern Center for Clinical Trials
Decatur, Georgia, United States, 30033