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

Phase 4

Completed

• Conditions: Thrombosis
• Interventions: Drug: Desirudin

• Registration Number: NCT00913133
• Lead Sponsor: Canyon Pharmaceuticals, Inc.

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.

Study Timeline

• Study First Submitted: 2009-05-26
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Study Start: 2010-03
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2012-11-30
• Results First Submitted QC: 2012-11-30
• Status Verified: 2013-01
• Results First Posted: 2013-01-03
• Last Update Submitted: 2013-01-06
• Last Update Posted: 2013-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 516

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Desirudin	Desirudin	desirudin 15 mg twice daily for a minimum of 5 days

Primary Outcome Measures

Name	Time	Method
Major Bleeding	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

Name	Time	Method
Thrombosis	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.

Trial Locations

Locations (15)

Saint Joseph's Research Institute; 🇺🇸 Atlanta, Georgia, United States

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

Drexel University College of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

Illinois Lung and Critical Care Institute; 🇺🇸 Peoria, Illinois, United States

St. John's Mercy Medical Center; 🇺🇸 St. Louis, Missouri, United States

University of South Florida, Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

University of Colorado Health Science Center; 🇺🇸 Aurora, Colorado, United States

Southeastern Center for Clinical Trials; 🇺🇸 Decatur, Georgia, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Overlook Hospital; 🇺🇸 Summit, New Jersey, United States

Forsyth Regional Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Stony Brook University Medical Center; 🇺🇸 Stony Brook, New York, United States

Carilion Roanoke Memorial Hospital; 🇺🇸 Roanoke, Virginia, United States

Provena St. Joseph's Medical Center; 🇺🇸 Joliet, Illinois, United States

Research Concepts, Memorial Hermann Healthcare System; 🇺🇸 Houston, Texas, United States