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

Multi-Center Trial of Desirudin for the Prophylaxis of Thrombosis: an Alternative to Heparin-Based Anticoagulation (DESIR-ABLE)

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.

Study Overview

• Status: Completed
• Conditions: Thrombosis
• Intervention / Treatment: Drug: Desirudin

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 516
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health Science Center
  • Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida, Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Saint Joseph's Research Institute
    • Decatur, Georgia, United States, 30033
      • Southeastern Center for Clinical Trials
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Provena St. Joseph's Medical Center
    • Peoria, Illinois, United States, 61606
      • Illinois Lung and Critical Care Institute
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • St. John's Mercy Medical Center
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Overlook Hospital
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • Stony Brook, New York, United States, 11794-8191
      • Stony Brook University Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 55902
      • Forsyth Regional Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Regional Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102-1192
      • Drexel University College of Medicine
  • Texas
    • Houston, Texas, United States, 77024
      • Research Concepts, Memorial Hermann Healthcare System
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Carilion Roanoke Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Desirudin; desirudin 15 mg twice daily for a minimum of 5 days	Drug: Desirudin; Desirudin SC 15mg q12h; Other Names: Iprivask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Bleeding	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.	24 hours after last dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombosis	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.	Up until 24 hours after last dose of study drug

Collaborators and Investigators

• Sponsor: Canyon Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Jerrold Levy, MD, FAHA, Emory University

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: May 26, 2009
• First Submitted That Met QC Criteria: June 3, 2009
• First Posted (Estimate): June 4, 2009

Study Record Updates

• Last Update Posted (Estimate): January 10, 2013
• Last Update Submitted That Met QC Criteria: January 6, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Anticoagulation; Prophylaxis; Heparin-induced thrombocytopenia; Direct thrombin inhibitor; Desirudin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Desirudin
• Other Study ID Numbers: DES-09-02