C David Mazer1, Richard P Whitlock1, Dean A Fergusson1, Judith Hall1, Emilie Belley-Cote1, Katherine Connolly1, Boris Khanykin1, Alexander J Gregory1, Étienne de Médicis1, Shay McGuinness1, Alistair Royse1, François M Carrier1, Paul J Young1, Juan C Villar1, Hilary P Grocott1, Manfred D Seeberger1, Stephen Fremes1, François Lellouche1, Summer Syed1, Kelly Byrne1, Sean M Bagshaw1, Nian C Hwang1, Chirag Mehta1, Thomas W Painter1, Colin Royse1, Subodh Verma1, Gregory M T Hare1, Ashley Cohen1, Kevin E Thorpe1, Peter Jüni1, Nadine Shehata1. 1. From the Department of Anesthesia (C.D.M., G.M.T.H.) and the Department of Surgery, Division of Cardiac Surgery (S.V.), Keenan Research Centre for Biomedical Science and Li Ka Shing Knowledge Institute of St. Michael's Hospital, Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital (J.H., A.C.), Sunnybrook Health Sciences Center (S.F.), AHRC, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Dalla Lana School of Public Health (K.E.T.), and AHRC, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation (P.J.), University of Toronto, and the Departments of Medicine, Laboratory Medicine, and Pathobiology, Institute of Health Policy, Management, and Evaluation, University of Toronto, and the Division of Hematology, Mount Sinai Hospital, Canadian Blood Services (N.S.), Toronto, Population Health Research Institute (R.P.W., E.B.-C.), Hamilton Health Sciences Centre (R.P.W., E.B.-C., K.C.), and McMaster University (R.P.W., E.B.-C., S.S.), Hamilton, ON, Ottawa Hospital Research Institute, University of Ottawa, Ottawa (D.A.F.), the Department of Anesthesia, Foothills Medical Centre, University of Calgary, Calgary, AB (A.J.G.), Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC (É.M.), the Departments of Anesthesia and Medicine, Division of Critical Care, Centre Hospitalier de l'Université de Montréal, Montreal (F.M.C.), the Departments of Anesthesia and Surgery, University of Manitoba, St. Boniface Hospital, Winnipeg (H.P.G.), the Department of Anesthesiology and Critical Care Medicine, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Laval University, Laval, QC (F.L.), and the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton (S.M.B.) - all in Canada; the Department of Cardiothoracic Anesthesia, Rigshospitalet, Copenhagen University Hospital, Copenhagen (B.K.); Medical Research Institute of New Zealand, Wellington (S.M., P.J.Y.), and Waikato Hospital, Hamilton (K.B.) - both in New Zealand; the Department of Surgery, University of Melbourne (A.R., C.R.), and the Department of Anaesthesia and Pain Management, Royal Melbourne Hospital (C.R.), Melbourne, VIC, and the Department of Anaesthesia, Royal Adelaide Hospital, Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA (T.W.P.) - all in Australia; Fundación Cardioinfantil-Instituto de Cardiología, Bogota, and Universidad Autónoma de Bucaramanga, Bucaramanga - both in Colombia (J.C.V.); the University of Basel, Department of Anesthesia, Surgical Intensive Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel, and Klinik Hirslanden, Zurich - both in Switzerland (M.D.S.); the Department of Cardiothoracic Anesthesia, National Heart Center, and the Department of Anesthesiology, Singapore General Hospital, Singapore (N.C.H.); and Heart Care Associates, Ahmedabad, India (C.M.).
Abstract
BACKGROUND: The effect of a restrictive versus liberal red-cell transfusion strategy on clinical outcomes in patients undergoing cardiac surgery remains unclear. METHODS: In this multicenter, open-label, noninferiority trial, we randomly assigned 5243 adults undergoing cardiac surgery who had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery) to a restrictive red-cell transfusion threshold (transfuse if hemoglobin level was <7.5 g per deciliter, starting from induction of anesthesia) or a liberal red-cell transfusion threshold (transfuse if hemoglobin level was <9.5 g per deciliter in the operating room or intensive care unit [ICU] or was <8.5 g per deciliter in the non-ICU ward). The primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first. Secondary outcomes included red-cell transfusion and other clinical outcomes. RESULTS: The primary outcome occurred in 11.4% of the patients in the restrictive-threshold group, as compared with 12.5% of those in the liberal-threshold group (absolute risk difference, -1.11 percentage points; 95% confidence interval [CI], -2.93 to 0.72; odds ratio, 0.90; 95% CI, 0.76 to 1.07; P<0.001 for noninferiority). Mortality was 3.0% in the restrictive-threshold group and 3.6% in the liberal-threshold group (odds ratio, 0.85; 95% CI, 0.62 to 1.16). Red-cell transfusion occurred in 52.3% of the patients in the restrictive-threshold group, as compared with 72.6% of those in the liberal-threshold group (odds ratio, 0.41; 95% CI, 0.37 to 0.47). There were no significant between-group differences with regard to the other secondary outcomes. CONCLUSIONS: In patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive strategy regarding red-cell transfusion was noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis, with less blood transfused. (Funded by the Canadian Institutes of Health Research and others; TRICS III ClinicalTrials.gov number, NCT02042898 .).
RCT Entities:
BACKGROUND: The effect of a restrictive versus liberal red-cell transfusion strategy on clinical outcomes in patients undergoing cardiac surgery remains unclear. METHODS: In this multicenter, open-label, noninferiority trial, we randomly assigned 5243 adults undergoing cardiac surgery who had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery) to a restrictive red-cell transfusion threshold (transfuse if hemoglobin level was <7.5 g per deciliter, starting from induction of anesthesia) or a liberal red-cell transfusion threshold (transfuse if hemoglobin level was <9.5 g per deciliter in the operating room or intensive care unit [ICU] or was <8.5 g per deciliter in the non-ICU ward). The primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first. Secondary outcomes included red-cell transfusion and other clinical outcomes. RESULTS: The primary outcome occurred in 11.4% of the patients in the restrictive-threshold group, as compared with 12.5% of those in the liberal-threshold group (absolute risk difference, -1.11 percentage points; 95% confidence interval [CI], -2.93 to 0.72; odds ratio, 0.90; 95% CI, 0.76 to 1.07; P<0.001 for noninferiority). Mortality was 3.0% in the restrictive-threshold group and 3.6% in the liberal-threshold group (odds ratio, 0.85; 95% CI, 0.62 to 1.16). Red-cell transfusion occurred in 52.3% of the patients in the restrictive-threshold group, as compared with 72.6% of those in the liberal-threshold group (odds ratio, 0.41; 95% CI, 0.37 to 0.47). There were no significant between-group differences with regard to the other secondary outcomes. CONCLUSIONS: In patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive strategy regarding red-cell transfusion was noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis, with less blood transfused. (Funded by the Canadian Institutes of Health Research and others; TRICS III ClinicalTrials.gov number, NCT02042898 .).
Authors: Babikir Kheiri; Ahmed Abdalla; Mohammed Osman; Tarek Haykal; Sai Chintalapati; James Cranford; Jason Sotzen; Meghan Gwinn; Sahar Ahmed; Mustafa Hassan; Ghassan Bachuwa; Deepak L Bhatt Journal: J Thromb Thrombolysis Date: 2019-02 Impact factor: 2.300
Authors: Amit X Garg; Neal Badner; Sean M Bagshaw; Meaghan S Cuerden; Dean A Fergusson; Alexander J Gregory; Judith Hall; Gregory M T Hare; Boris Khanykin; Shay McGuinness; Chirag R Parikh; Pavel S Roshanov; Nadine Shehata; Jessica M Sontrop; Summer Syed; George I Tagarakis; Kevin E Thorpe; Subodh Verma; Ron Wald; Richard P Whitlock; C David Mazer Journal: J Am Soc Nephrol Date: 2019-06-20 Impact factor: 10.121
Authors: Nadine Shehata; Nikhil Mistry; Bruno R da Costa; Tiago V Pereira; Richard Whitlock; Gerard F Curley; David A Scott; Gregory M T Hare; Peter Jüni; C David Mazer Journal: Eur Heart J Date: 2019-04-01 Impact factor: 29.983
Authors: C J Reuß; M Bernhard; C Beynon; A Hecker; C Jungk; C Nusshag; M A Weigand; D Michalski; T Brenner Journal: Anaesthesist Date: 2018-09 Impact factor: 1.041
Authors: Steven M Frank; Robert A Sikorski; Gerhardt Konig; Diamantis I Tsilimigras; Jan Hartmann; Mark A Popovsky; Timothy M Pawlik; Jonathan H Waters Journal: J Gastrointest Surg Date: 2019-08-29 Impact factor: 3.452