RT Journal Article
SR Electronic
T1 Bleeding impacting mortality after noncardiac surgery: a protocol to establish diagnostic criteria, estimate prognostic importance, and develop and validate a prediction guide in an international prospective cohort study
JF CMAJ Open
FD Canadian Medical Association
SP E594
OP E603
DO 10.9778/cmajo.20160106
VO 5
IS 3
A1 Pavel S. Roshanov
A1 John W. Eikelboom
A1 Mark Crowther
A1 Vikas Tandon
A1 Flavia K. Borges
A1 Clive Kearon
A1 Andre Lamy
A1 Richard Whitlock
A1 Bruce M. Biccard
A1 Wojciech Szczeklik
A1 Gordon H. Guyatt
A1 Mohamed Panju
A1 Jessica Spence
A1 Amit X. Garg
A1 Michael McGillion
A1 Tomas VanHelder
A1 Peter A. Kavsak
A1 Justin de Beer
A1 Mitchell Winemaker
A1 Daniel I. Sessler
A1 Yannick Le Manach
A1 Tej Sheth
A1 Jehonathan H. Pinthus
A1 Lehana Thabane
A1 Marko R.I. Simunovic
A1 Ryszard Mizera
A1 Sebastian Ribas
A1 P.J. Devereaux
A1 the Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION)
A1 Investigators
YR 2017
UL http://www.cmajopen.ca/content/5/3/E594.abstract
AB Introduction: Various 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.Methods: In 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.Interpretation: This 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.