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 Roshanov, Pavel S.
A1 Eikelboom, John W.
A1 Crowther, Mark
A1 Tandon, Vikas
A1 Borges, Flavia K.
A1 Kearon, Clive
A1 Lamy, Andre
A1 Whitlock, Richard
A1 Biccard, Bruce M.
A1 Szczeklik, Wojciech
A1 Guyatt, Gordon H.
A1 Panju, Mohamed
A1 Spence, Jessica
A1 Garg, Amit X.
A1 McGillion, Michael
A1 VanHelder, Tomas
A1 Kavsak, Peter A.
A1 de Beer, Justin
A1 Winemaker, Mitchell
A1 Sessler, Daniel I.
A1 Le Manach, Yannick
A1 Sheth, Tej
A1 Pinthus, Jehonathan H.
A1 Thabane, Lehana
A1 Simunovic, Marko R.I.
A1 Mizera, Ryszard
A1 Ribas, Sebastian
A1 Devereaux, P.J.
A1 ,
A1 ,
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.