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.
Hospitalized patients who require DVT prophylaxis and who are not good candidates for heparin-based anti-coagulation were eligible.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
516
Desirudin SC 15mg q12h
University of Colorado Health Science Center
Aurora, Colorado, United States
University of South Florida, Tampa General Hospital
Tampa, Florida, United States
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.
Time frame: 24 hours after last dose of study drug
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.
Time frame: Up until 24 hours after last dose of study drug
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