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

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

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

Conditions
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Thrombosis

Intervention / Treatment
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* Drug: Desirudin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desirudin<br>desirudin 15 mg twice daily for a minimum of 5 days | Drug: Desirudin<br>* Desirudin SC 15mg q12h<br>* Other names: Iprivask;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anticoagulation, Prophylaxis, Desirudin, Direct thrombin inhibitor, Heparin-induced thrombocytopenia