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

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

Inclusion criteria

• Provide written informed consent before initiation of any study related procedures.
• Be at least 18 years of age.
• Patients requiring anticoagulation for the prophylaxis of thrombosis.
• In the opinion of the Investigator, an alternative to heparin-based anticoagulant therapies is desirable.

Exclusion criteria

• Confirmed pregnancy (if woman of child-bearing potential) (urine or serum pregnancy test).
• Intracranial neoplasm, arteriovenous malformation or aneurysm.
• 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.
• Known allergy to desirudin or hirudin-derived drugs, or known sensitivity to any component of the product
• 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).
• Refusal to undergo blood transfusion should it become necessary
• Active bleeding or irreversible coagulation abnormality.
• Uncontrolled hypertension defined as a blood pressure > or equal to 180/110 mmHg.
• Patients requiring anticoagulation for left-ventricular assist device, intra-aortic balloon pump, veno-venous ultra filtration or ECMO.
• 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.