Development of a standardized definition for clinically significant bleeding in the ASPirin in Reducing Events in the Elderly (ASPREE) trial.

Contemporary Clinical Trials Communications
Karen L MargolisErica M Wood

Abstract

Bleeding is the major risk of aspirin treatment, especially in the elderly. A consensus definition for clinically significant bleeding (CSB) in aspirin primary prevention trials is lacking in the literature. This paper details the development, modification, application, and quality control of a definition for clinically significant bleeding in the ASPirin in Reducing Events in the Elderly (ASPREE) trial, a primary prevention trial of aspirin in 19,114 community-dwelling elderly men and women. In ASPREE a confirmed bleeding event needed to meet criteria both for substantiated bleeding and clinical significance. Substantiated bleeding was defined as: 1) observed bleeding, 2) a reasonable report of symptoms of bleeding, 3) medical, nursing or paramedical report, or 4) imaging evidence. Bleeding was defined as clinically significant if it: 1) required transfusion of red blood cells, 2) required admission to the hospital for >24 h, or prolonged a hospitalization, with bleeding as the principal reason, 3) required surgery to stop the bleeding, or 4) resulted in death. Bleeding sites were subclassified as upper gastrointestinal, lower gastrointestinal, intracranial (hemorrhagic stroke, subarachnoid hemorrhage, subdural hematoma, extra...Continue Reading

Associated Clinical Trials

Citations

Sep 18, 2018·The New England Journal of Medicine·John J McNeilUNKNOWN ASPREE Investigator Group
Feb 19, 2019·The Medical Journal of Australia·James P Sheppard, Chris Butler
Dec 29, 2020·The Journals of Gerontology. Series A, Biological Sciences and Medical Sciences·Robyn L WoodsAnne B Newman
Aug 20, 2020·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Tariq KewanHamed Daw
May 21, 2021·Digestive Diseases and Sciences·Yousef ElfanagelySarah M Hyder

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Methods Mentioned

BETA
coronary bypass
dissection

Software Mentioned

ASPREE

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