• Pavel S Roshanov, John W Eikelboom, Mark Crowther, Vikas Tandon, Flavia K Borges, Clive Kearon, Andre Lamy, Richard Whitlock, Bruce M Biccard, Wojciech Szczeklik, Gordon H Guyatt, Mohamed Panju, Jessica Spence, Amit X Garg, Michael McGillion, Tomas VanHelder, Peter A Kavsak, Justin de Beer, Mitchell Winemaker, Daniel I Sessler, Yannick Le Manach, Tej Sheth, Jehonathan H Pinthus, Lehana Thabane, Marko R I Simunovic, Ryszard Mizera, Sebastian Ribas, P J Devereaux, and Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Investigators.
• Affiliations: Lilibeth Caberto Kidney Clinical Research Unit (Roshanov, Garg), London Health Sciences Centre, London, Ont.; Department of Medicine (Eikelboom, Tandon, Borges, Kearon, Panju, Sheth, Mizera, Ribas, Devereaux), Department of Surgery (Lamy, Whitlock, de Beer, Winemaker, Pinthus, Simunovic), Department of Health Research Methods, Evidence, and Impact (Lamy, Guyatt, Le Manach, Thabane, Simunovic, Devereaux), Department of Pathology and Molecular Medicine (Crowther, Kavsak), Department of Anesthesia (Spence, VanHelder, Le Manach), Thrombosis and Atherosclerosis Research Institute (Kearon) and School of Nursing (McGillion), Faculty of Health Sciences, McMaster University, Hamilton, Ont.; Population Health Research Institute (Eikelboom, Borges, Lamy, Whitlock, Spence, McGillion, Le Manach, Devereaux), Hamilton, Ont.; Department of Anaesthesia and Perioperative Medicine (Biccard), Groote Schuur Hospital, Observatory, South Africa, and University of Cape Town, South Africa; Department of Intensive Care and Perioperative Medicine (Szczeklik), Jagiellonian University Medical College, Krakow, Poland; Institute for Clinical Evaluative Sciences at Western (Garg), London, Ont.; Faculty of Health and Life Sciences (McGillion), Coventry University, Coventry, United Kingdom; Department of Outcomes Research (Sessler), Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont.
• CMAJ Open. 2017 Aug 4; 5 (3): E594-E603.

IntroductionVarious definitions of bleeding have been used in perioperative studies without systematic assessment of the diagnostic criteria for their independent association with outcomes important to patients. Our proposed definition of bleeding impacting mortality after noncardiac surgery (BIMS) is bleeding that is independently associated with death during or within 30 days after noncardiac surgery. We describe our analysis plan to sequentially 1) establish the diagnostic criteria for BIMS, 2) estimate the independent contribution of BIMS to 30-day mortality and 3) develop and internally validate a clinical prediction guide to estimate patient-specific risk of BIMS.MethodsIn the Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) study, we prospectively collected bleeding data for 16 079 patients aged 45 years or more who had noncardiac inpatient surgery between 2007 and 2011 at 12 centres in 8 countries across 5 continents. We will include bleeding features independently associated with 30-day mortality in the diagnostic criteria for BIMS. Candidate features will include the need for reoperation due to bleeding, the number of units of erythrocytes transfused, the lowest postoperative hemoglobin concentration, and the absolute and relative decrements in hemoglobin concentration from the preoperative value. We will then estimate the incidence of BIMS and its independent association with 30-day mortality. Last, we will construct and internally validate a clinical prediction guide for BIMS.InterpretationThis study will address an important gap in our knowledge about perioperative bleeding, with implications for the 200 million patients who undergo noncardiac surgery globally every year. Trial registration: ClinicalTrials.gov, no NCT00512109.Copyright 2017, Joule Inc. or its licensors.

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