Development and validation of an intraoperative bleeding severity scale for use in clinical studies of hemostatic agents

摘要

Background. Clinical studies investigating topical hemostatic agents have not used standardized definitions for intraoperative bleeding. The Food and Drug Administration has recently sought use of a validated, clinician-reported scale to standardized bleeding sites in these clinical studies. The intent of a scale is to reduce patient risk, generate labeling claims, and allow comparisons among study results. We describe the development and validation of an intraoperative bleeding severity scale.