title: Aneurysmal SubArachnoid Hemorrhage-Red Blood Cell Transfusion And Outcome (SAHaRA): a pilot randomised controlled trial protocol.
abstract: Anaemia is common in aneurysmal subarachnoid haemorrhage (aSAH) and is a potential critical modifiable factor affecting secondary injury. Despite physiological evidence and management guidelines that support maintaining a higher haemoglobin level in patients with aSAH, current practice is one of a more restrictive approach to transfusion. The goal of this multicentre pilot trial is to determine the feasibility of successfully conducting a red blood cell (RBC) transfusion trial in adult patients with acute aSAH and anaemia (Hb ≤100 g/L), comparing a liberal transfusion strategy (Hb ≤100 g/L) with a restrictive strategy (Hb ≤80 g/L) on the combined rate of death and severe disability at 12 months.
  
  
  
  Design This is a multicentre open-label randomised controlled pilot trial at 5 academic tertiary care centres. Population We are targeting adult aSAH patients within 14 days of their initial bleed and with anaemia (Hb ≤110 g/L). Randomisation Central computer-generated randomisation, stratified by centre, will be undertaken from the host centre. Randomisation into 1 of the 2 treatment arms will occur when the haemoglobin levels of eligible patients fall to ≤100 g/L. Intervention Patients will be randomly assigned to either a liberal (threshold: Hb ≤100 g/L) or a restrictive transfusion strategy (threshold: Hb ≤80 g/L). Outcome Primary: Centre randomisation rate over the study period. Secondary: (1) transfusion threshold adherence; (2) study RBC transfusion protocol adherence; and (3) outcome assessment including vital status at hospital discharge, modified Rankin Score at 6 and 12 months and Functional Independence Measure and EuroQOL Quality of Life Scale scores at 12 months. Outcome measures will be reported in aggregate.
  
  
  
  The study protocol has been approved by the host centre (OHSN-REB 20150433-01H). This study will determine the feasibility of conducting the large pragmatic RCT comparing 2 RBC transfusion strategies examining the effect of a liberal strategy on 12-month outcome following aSAH.
  
  
  
  NCT02483351; Pre-results.
authors.affiliation: Department of Medicine (Critical Care), University of Ottawa, Ottawa, Ontario, Canada.|Clinical Epidemiology Program (Centre for Transfusion Research), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
authors.forename: Shane W
authors.initials: SW
authors.lastname: English
authors.affiliation: Clinical Epidemiology Program (Centre for Transfusion Research), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.|Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: D
authors.initials: D
authors.lastname: Fergusson
authors.affiliation: Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Evaluation, Care Systems and Services Theme, Montréal, Québec, Canada.|Department of Medicine (Critical Care), Université de Montréal, Montréal, Québec, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Chassé
authors.affiliation: Department of Anesthesiology and Critical Care, Division of Critical Care Medicine, Université Laval, Québec City, Quebec, Canada.|Population Health and Optimal Health Practices Unit (Trauma-Emergency-Critical Care Medicine), CHU de Québec-Université Laval Research Center, Québec City, Quebec, Canada.
authors.forename: A F
authors.identifier: 0000-0001-5675-8791
authors.initials: AF
authors.lastname: Turgeon
authors.affiliation: Department of Anesthesiology and Critical Care, Division of Critical Care Medicine, Université Laval, Québec City, Quebec, Canada.|Population Health and Optimal Health Practices Unit (Trauma-Emergency-Critical Care Medicine), CHU de Québec-Université Laval Research Center, Québec City, Quebec, Canada.|Department of Medicine, Université Laval, Québec City, Quebec, Canada.
authors.forename: F
authors.initials: F
authors.lastname: Lauzier
authors.affiliation: Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: D
authors.initials: D
authors.lastname: Griesdale
authors.affiliation: Department of Surgery (Neurosurgery), McMaster University, Hamilton, Ontario, Canada.
authors.forename: A
authors.initials: A
authors.lastname: Algird
authors.affiliation: Department of Critical Care Medicine, University of Calgary, Calgary, Alberta, Canada.|Department of Clinical Neurosciences, The Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada.
authors.forename: A
authors.initials: A
authors.lastname: Kramer
authors.affiliation: Clinical Epidemiology Program (Centre for Transfusion Research), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.|Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: A
authors.initials: A
authors.lastname: Tinmouth
authors.affiliation: Clinical Epidemiology Program (Centre for Transfusion Research), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
authors.forename: C
authors.initials: C
authors.lastname: Lum
authors.affiliation: Clinical Epidemiology Program (Centre for Transfusion Research), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
authors.forename: J
authors.initials: J
authors.lastname: Sinclair
authors.affiliation: Clinical Epidemiology Program (Centre for Transfusion Research), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.|Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: S
authors.initials: S
authors.lastname: Marshall
authors.affiliation: Clinical Epidemiology Program (Centre for Transfusion Research), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.|Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: D
authors.initials: D
authors.lastname: Dowlatshahi
authors.affiliation: Population Health and Optimal Health Practices Unit (Trauma-Emergency-Critical Care Medicine), CHU de Québec-Université Laval Research Center, Québec City, Quebec, Canada.
authors.forename: A
authors.initials: A
authors.lastname: Boutin
authors.affiliation: Clinical Epidemiology Program (Centre for Transfusion Research), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
authors.forename: G
authors.initials: G
authors.lastname: Pagliarello
authors.affiliation: Department of Medicine (Critical Care), University of Ottawa, Ottawa, Ontario, Canada.|Clinical Epidemiology Program (Centre for Transfusion Research), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
authors.forename: L A
authors.initials: LA
authors.lastname: McIntyre
mesh_terms: D000740:Anemia / Q000401:mortality; D002985:Clinical Protocols; D003422:Critical Care; D004185:Disability Evaluation; D057510:Endovascular Procedures / Q000379:methods* / Q000401:mortality; D017707:Erythrocyte Transfusion / Q000379:methods / Q000401:mortality; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D009656:North America / Q000453:epidemiology; D017063:Outcome Assessment, Health Care; D010865:Pilot Projects; D011788:Quality of Life; D012307:Risk Factors; D013345:Subarachnoid Hemorrhage / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D016896:Treatment Outcome
keywords: NEUROSURGERY