title: Standardized reporting of bleeding complications for clinical investigations in acute coronary syndromes: a proposal from the academic bleeding consensus (ABC) multidisciplinary working group.
abstract: BACKGROUND
  Clinical trials of antithrombotic agents for the treatment of ACS routinely assess bleeding as a safety endpoint, but variation in bleeding definitions makes comparison of the relative safety of these agents difficult.
  
  
  METHODS
  The ABC Multidisciplinary Working Group, an informal working group comprising clinical researchers and representatives from the US Food and Drug Administration, the National Institutes of Health, and the pharmaceutical industry, sought to develop a consensus approach to measuring the incidence and severity of bleeding complications during clinical trials of acute coronary syndromes (ACS). A meeting of the ABC was convened in April 2008 in Washington, DC, with the goal of developing a consensus approach to measuring the incidence and severity of hemorrhagic complications during clinical trials of ACS. Relevant literature on bleeding was reviewed through a series of short lectures and intensive group discussion.
  
  
  RESULTS
  Using existing evidence on bleeding and outcomes as well as clinical judgment, criteria for the assessment of bleeding were developed through expert consensus. This consensus statement divides bleeding-related data elements into three categories: essential, recommended, and optional.
  
  
  CONCLUSIONS
  The ABC Group recommendations for collection and reporting of bleeding complications provide a framework for consistency in the collection of information on hemorrhagic complications in trials of ACS. Widespread adoption of the statement recommendations will facilitate understanding of the mechanisms of adverse outcomes after bleeding and comparisons of the relative safety of antithrombotic agents, as well as the interpretation of safety results from future studies.
authors: Duke Clinical Research Institute, Durham, NC 27705, USA. sunil.rao@duke.edu
authors: Sunil V
authors: SV
authors: Rao
authors: John
authors: J
authors: Eikelboom
authors: Ph Gabriel
authors: PG
authors: Steg
authors: A Michael
authors: AM
authors: Lincoff
authors: William S
authors: WS
authors: Weintraub
authors: Jean-Pierre
authors: JP
authors: Bassand
authors: A Koneti
authors: AK
authors: Rao
authors: C Michael
authors: CM
authors: Gibson
authors: John L
authors: JL
authors: Petersen
authors: Roxana
authors: R
authors: Mehran
authors: Steven V
authors: SV
authors: Manoukian
authors: Richard
authors: R
authors: Charnigo
authors: Kerry L
authors: KL
authors: Lee
authors: Mauro
authors: M
authors: Moscucci
authors: Robert A
authors: RA
authors: Harrington
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy*; D005343:Fibrinolytic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D006470:Hemorrhage / Q000139:chemically induced* / Q000517:prevention & control; D006801:Humans; D012107:Research Design / Q000592:standards*
chemical_list: D005343:Fibrinolytic Agents