Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis

Thrombosis Clinical Trial

— DESIR-ABLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913133
• Other study ID #: DES-09-02
• Status: Completed
• Phase: Phase 4
• First received: May 26, 2009
• Last updated: January 6, 2013
• Start date: March 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2013
• Source: Canyon Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• Desirudin
Desirudin SC 15mg q12h

Locations

Country	Name	City	State
United States	Saint Joseph's Research Institute	Atlanta	Georgia
United States	University of Colorado Health Science Center	Aurora	Colorado
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Southeastern Center for Clinical Trials	Decatur	Georgia
United States	Research Concepts, Memorial Hermann Healthcare System	Houston	Texas
United States	Provena St. Joseph's Medical Center	Joliet	Illinois
United States	Weill Cornell Medical College	New York	New York
United States	Illinois Lung and Critical Care Institute	Peoria	Illinois
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia
United States	St. John's Mercy Medical Center	St. Louis	Missouri
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Overlook Hospital	Summit	New Jersey
United States	University of South Florida, Tampa General Hospital	Tampa	Florida
United States	Forsyth Regional Medical Center	Winston-Salem	North Carolina
United States	Forsyth Regional Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Canyon Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes