Assessments

The primary efficacy assessment was a composite endpoint of all-cause death, all-cause amputation, or new thrombosis within a 37-day study period. Additional analyses included the evaluation of event rates for the components of the composite endpoint and death due to thrombosis. Secondary efficacy endpoints included the achievement of adequate anticoagulation (i.e., an aPTT >1.5 times baseline) and resolution of thrombocytopenia (i.e., platelet count >100 X 109/L or >1.5 times baseline by study day 3).

Major bleeding was defined as overt and associated with a hemoglobin decrease >2g/dL that led to a transfusion of >2 units or that was intracranial, retroperitoneal, or into a major prosthetic joint. Other overt bleeding was considered minor.

0 0

Post a comment