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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Canyon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00913133
First received: May 26, 2009
Last updated: January 6, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Thrombosis
Drug: Desirudin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Canyon Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Major Bleeding [ Time Frame: 24 hours after last dose of study drug ] [ Designated as safety issue: Yes ]
    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:
  • Thrombosis [ Time Frame: Up until 24 hours after last dose of study drug ] [ Designated as safety issue: Yes ]
    • 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.


Enrollment: 516
Study Start Date: March 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desirudin
desirudin 15 mg twice daily for a minimum of 5 days
Drug: Desirudin
Desirudin SC 15mg q12h
Other Name: Iprivask

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913133

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, 55902
Forsyth Regional Medical Center
Winston-Salem, North Carolina, United States, 27103
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

No publications provided

Responsible Party: Canyon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00913133     History of Changes
Other Study ID Numbers: DES-09-02
Study First Received: May 26, 2009
Results First Received: November 30, 2012
Last Updated: January 6, 2013
Health Authority: United States: Food and Drug Administration

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
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 19, 2014