What is the definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients?
In clinical investigations of antihemostatic medicinal products in non-surgical patients, major bleeding is defined as bleeding associated with a decrease in hemoglobin of 2 g/dL, bleeding in a critical area or organ (e.g. intracranial, intraocular, retroperitoneal, intra-articular or pericardial), or bleeding that results in transfusion of 2 or more units of blood.