Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis (DESIR-ABLE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00913133 |
Recruitment Status :
Completed
First Posted : June 4, 2009
Results First Posted : January 3, 2013
Last Update Posted : January 10, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Thrombosis | Drug: Desirudin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 516 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Multi-Center Trial of Desirudin for the Prophylaxis of Thrombosis: an Alternative to Heparin-Based Anticoagulation (DESIR-ABLE) |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Desirudin
desirudin 15 mg twice daily for a minimum of 5 days
|
Drug: Desirudin
Desirudin SC 15mg q12h
Other Name: Iprivask |
- Major Bleeding [ Time Frame: 24 hours after last dose of study drug ]Major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the peri-operative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint.
- Thrombosis [ Time Frame: Up until 24 hours after last dose of study drug ]
- New onset symptomatic thrombosis requiring medical or surgical intervention;
- Death due to thrombosis defined as fatal pulmonary embolism, ischemic stroke, mesenteric thrombosis or myocardial infarction.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913133
United States, Colorado | |
University of Colorado Health Science Center | |
Aurora, Colorado, United States, 80045 | |
United States, Florida | |
University of South Florida, Tampa General Hospital | |
Tampa, Florida, United States, 33606 | |
United States, Georgia | |
Saint Joseph's Research Institute | |
Atlanta, Georgia, United States, 30342 | |
Southeastern Center for Clinical Trials | |
Decatur, Georgia, United States, 30033 | |
United States, Illinois | |
Provena St. Joseph's Medical Center | |
Joliet, Illinois, United States, 60435 | |
Illinois Lung and Critical Care Institute | |
Peoria, Illinois, United States, 61606 | |
United States, Missouri | |
St. John's Mercy Medical Center | |
St. Louis, Missouri, United States, 63141 | |
United States, New Jersey | |
Overlook Hospital | |
Summit, New Jersey, United States, 07901 | |
United States, New York | |
Weill Cornell Medical College | |
New York, New York, United States, 10065 | |
Stony Brook University Medical Center | |
Stony Brook, New York, United States, 11794-8191 | |
United States, North Carolina | |
Forsyth Regional Medical Center | |
Winston-Salem, North Carolina, United States, 27103 | |
Forsyth Regional Medical Center | |
Winston-Salem, North Carolina, United States, 55902 | |
United States, Ohio | |
The Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
Drexel University College of Medicine | |
Philadelphia, Pennsylvania, United States, 19102-1192 | |
United States, Texas | |
Research Concepts, Memorial Hermann Healthcare System | |
Houston, Texas, United States, 77024 | |
United States, Virginia | |
Carilion Roanoke Memorial Hospital | |
Roanoke, Virginia, United States, 24014 |
Study Director: | Dawn Bell, PharmD | Canyon Pharmaceuticals, Inc. | |
Principal Investigator: | Jerrold Levy, MD, FAHA | Emory University |
Responsible Party: | Canyon Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00913133 |
Other Study ID Numbers: |
DES-09-02 |
First Posted: | June 4, 2009 Key Record Dates |
Results First Posted: | January 3, 2013 |
Last Update Posted: | January 10, 2013 |
Last Verified: | January 2013 |
Anticoagulation Prophylaxis Desirudin Direct thrombin inhibitor Heparin-induced thrombocytopenia |
Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Desirudin |
Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |