Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis (DESIR-ABLE)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Thrombosis	Drug: Desirudin	Phase 4

Detailed Description:

Hospitalized patients who require DVT prophylaxis and who are not good candidates for heparin-based anti-coagulation were eligible.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	516 participants
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

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Provide written informed consent before initiation of any study related procedures.
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:

1. Confirmed pregnancy (if woman of child-bearing potential) (urine or serum pregnancy test).
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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Canyon Pharmaceuticals, Inc.

Investigators

Study Director:	Dawn Bell, PharmD	Canyon Pharmaceuticals, Inc.
Principal Investigator:	Jerrold Levy, MD, FAHA	Emory University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Canyon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00913133 History of Changes
Other Study ID Numbers:	DES-09-02
First Posted:	June 4, 2009
Results First Posted:	January 3, 2013
Last Update Posted:	January 10, 2013
Last Verified:	January 2013

Keywords provided by Canyon Pharmaceuticals, Inc.:

Anticoagulation; Prophylaxis; Desirudin; Direct thrombin inhibitor; Heparin-induced thrombocytopenia

Additional relevant MeSH terms:

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Desirudin; Heparin; Hirudins; Anticoagulants	Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors