Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5734839 | Surgery | 2017 | 11 Pages |
Abstract
This study validated an intraoperative bleeding severity scale for use in clinical studies investigating hemostatic agents. The scale was usable, clear, and clinically relevant with excellent reliability. The scale fulfills requirements of the Food and Drug Administration for a clinician-reported scale and can be used to generate clinically meaningful labeling claims.
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Authors
Kevin M. DVM, Qing MD, PhD, Drew S. MD, MPH, MBA, JoMichelle D. PhD, Hongyan MB, MS, PStat, Philippe E. MD, MS, FRCSC(C), Emanuele MD, PhD, FACS, FASMBS, Abe MD, FACS, FAHA,