What is the definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients?
The definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients was established by Schulman and Kearon in 2005 and involves any clinically overt bleeding that satisfies at least one of the following criteria: bleeding associated with a decrease in hemoglobin level of 2 g/dL or more, transfusion of 2 or more units of whole blood or packed red blood cells, bleeding in a critical area or organ, bleeding that was fatal, and any other clinically significant bleeding that required medical intervention or hospitalization.