Clinical trial NCT00913133: Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis
Official title: Multi-Center Trial of Desirudin for the Prophylaxis of Thrombosis: an Alternative to Heparin-Based Anticoagulation (DESIR-ABLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thrombosis
Keywords: Anticoagulation
Prophylaxis
Desirudin
Direct thrombin inhibitor
Heparin-induced thrombocytopenia
Lead sponsor: Canyon Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility 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.

Primary outcomes:
measure: Major Bleeding
timeFrame: 24 hours after last dose of study drug
Secondary outcomes:
measure: Thrombosis
timeFrame: Up until 24 hours after last dose of study drug
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Health Science Center
state: Colorado
city: Tampa
country: United States
facility: University of South Florida, Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Saint Joseph's Research Institute
state: Georgia
city: Decatur
country: United States
facility: Southeastern Center for Clinical Trials
state: Georgia
city: Joliet
country: United States
facility: Provena St. Joseph's Medical Center
state: Illinois
city: Peoria
country: United States
facility: Illinois Lung and Critical Care Institute
state: Illinois
city: St. Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
city: Summit
country: United States
facility: Overlook Hospital
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Forsyth Regional Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Regional Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Houston
country: United States
facility: Research Concepts, Memorial Hermann Healthcare System
state: Texas
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
Study officials:
affiliation: Canyon Pharmaceuticals, Inc.
name: Dawn Bell, PharmD
role: STUDY_DIRECTOR
affiliation: Emory University
name: Jerrold Levy, MD, FAHA
role: PRINCIPAL_INVESTIGATOR
References: