Phase 4
N=516
Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis
Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT00913133 ↗Enrolled (actual)
516
Serious AEs
15.5%
Results posted
Jan 2013
Primary outcome: Primary: Major Bleeding — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Desirudin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Canyon Pharmaceuticals, Inc.
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Bleeding |
— | — |
| SECONDARY Thrombosis |
8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT00913133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.