Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol

Alexis F Turgeon; Dean A Fergusson; Lucy Clayton; Marie-Pier Patton; Ryan Zarychanski; Shane English; Annemarie Docherty; Timothy Walsh; Donald Griesdale; Andreas H Kramer; Damon Scales; Karen E A Burns; John Gordon Boyd; John C Marshall; Demetrios J Kutsogiannis; Ian Ball; Paul C Hébert; Francois Lamontagne; Olivier Costerousse; Maude St-Onge; Paule Lessard Bonaventure; Lynne Moore; Xavier Neveu; Andrea Rigamonti; Kosar Khwaja; Robert S Green; Vincent Laroche; Alison Fox-Robichaud; Francois Lauzier; HEMOTION Trial Team, the Canadian Critical Care Trials Group, the Canadian Perioperative Anesthesia Clinical Trials Group and the Canadian Traumatic Brain Injury Research Consortium

doi:10.1136/bmjopen-2022-067117

Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol

BMJ Open. 2022 Oct 10;12(10):e067117. doi: 10.1136/bmjopen-2022-067117.

Authors

Alexis F Turgeon^{1

2}, Dean A Fergusson^{3

4}, Lucy Clayton^{5

6}, Marie-Pier Patton⁵, Ryan Zarychanski^{7

8}, Shane English^{3

4

9}, Annemarie Docherty¹⁰, Timothy Walsh¹⁰, Donald Griesdale^{11

12

13}, Andreas H Kramer¹⁴, Damon Scales^{15

16}, Karen E A Burns^{15

17}, John Gordon Boyd^{18

19}, John C Marshall^{15

17

20}, Demetrios J Kutsogiannis²¹, Ian Ball^{22

23}, Paul C Hébert²⁴, Francois Lamontagne^{25

26}, Olivier Costerousse⁵, Maude St-Onge^{5

2

27}, Paule Lessard Bonaventure^{5

28}, Lynne Moore^{5

29}, Xavier Neveu⁵, Andrea Rigamonti^{15

30}, Kosar Khwaja³¹, Robert S Green^{32

33}, Vincent Laroche^{5

34}, Alison Fox-Robichaud³⁵, Francois Lauzier^{5

2

34}; HEMOTION Trial Team, the Canadian Critical Care Trials Group, the Canadian Perioperative Anesthesia Clinical Trials Group and the Canadian Traumatic Brain Injury Research Consortium

Affiliations

¹ Population Health and Optimal Practices Research Unit (Trauma- Emergency-Critical Care Medicine), CHU de Québec-Universite Laval Research Center, Québec City, Québec, Canada alexis.turgeon@fmed.ulaval.ca.
² Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Université Laval, Québec City, Québec, Canada.
³ Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
⁴ Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
⁵ Population Health and Optimal Practices Research Unit (Trauma- Emergency-Critical Care Medicine), CHU de Québec-Universite Laval Research Center, Québec City, Québec, Canada.
⁶ Centre de Recherche du CHU Sainte-Justine, Montréal, Québec, Canada.
⁷ Department of Internal Medicine, Section of Hematology/Oncology, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
⁸ CancerCare Manitoba Research Institute, CancerCare Manitoba, Winnipeg, Manitoba, Canada.
⁹ Department of Critical Care, The Ottawa Hospital, Ottawa, Ontario, Canada.
¹⁰ Centre for Medical Informatics, Usher Institute, The University of Edinburgh, Edinburgh, UK.
¹¹ Department of Anesthesiology, Pharmacology, and Therapeutics, University of British Columbia, Vancouver, British Columbia, Canada.
¹² Division of Critical Care Medicine, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
¹³ Center for Clinical Epidemiology & Evaluation, Vancouver General Hospital, Vancouver Coastal Health Research Institute, Vancouver, British Columbia, Canada.
¹⁴ Department of Critical Care Medicine, Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada.
¹⁵ Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada.
¹⁶ Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
¹⁷ Li Ka Shing Knowledge Institute, Unity Health Toronto-St. Michael's Hospital, Toronto, Ontario, Canada.
¹⁸ Department of Medicine, Division of Neurology, Queen's University, Kingston, Ontario, Canada.
¹⁹ Department of Medicine, Division of Critical Care Medicine, Queen's University, Kingston, Ontario, Canada.
²⁰ Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
²¹ Department of Critical Care Medicine, University of Alberta, Edmonton, Alberta, Canada.
²² Department of Medicine, Western University, London, Ontario, Canada.
²³ Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
²⁴ Department of Medicine, Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.
²⁵ Department of Medicine, Université de Sherbrooke, Sherbrooke, Québec, Canada.
²⁶ Centre de Recherche du CHU de Sherbrooke, Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec, Canada.
²⁷ Department of Family and Emergency Medicine, Université Laval, Québec City, Québec, Canada.
²⁸ Department of Surgery, Division of Neurosurgery, Université Laval, Québec City, Québec, Canada.
²⁹ Department of Social and Preventive Medicine, Université Laval, Québec City, Québec, Canada.
³⁰ Department of Anesthesiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
³¹ Department of Critical Care Medicine, McGill University, Montréal, Québec, Canada.
³² Departments of Emergency Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
³³ Department of Critical Care, Dalhousie University, Halifax, Nova Scotia, Canada.
³⁴ Department of Medicine, Université Laval, Québec City, Québec, Canada.
³⁵ Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.

Abstract

Introduction: Traumatic brain injury (TBI) is the leading cause of mortality and long-term disability in young adults. Despite the high prevalence of anaemia and red blood cell transfusion in patients with TBI, the optimal haemoglobin (Hb) transfusion threshold is unknown. We undertook a randomised trial to evaluate whether a liberal transfusion strategy improves clinical outcomes compared with a restrictive strategy.

Methods and analysis: HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatiON is an international pragmatic randomised open label blinded-endpoint clinical trial. We will include 742 adult patients admitted to an intensive care unit (ICU) with an acute moderate or severe blunt TBI (Glasgow Coma Scale ≤12) and a Hb level ≤100 g/L. Patients are randomly allocated using a 1:1 ratio, stratified by site, to a liberal (triggered by Hb ≤100 g/L) or a restrictive (triggered by Hb ≤70 g/L) transfusion strategy applied from the time of randomisation to the decision to withdraw life-sustaining therapies, ICU discharge or death. Primary and secondary outcomes are assessed centrally by trained research personnel blinded to the intervention. The primary outcome is the Glasgow Outcome Scale extended at 6 months. Secondary outcomes include overall functional independence measure, overall quality of life (EuroQoL 5-Dimension 5-Level; EQ-5D-5L), TBI-specific quality of life (Quality of Life after Brain Injury; QOLIBRI), depression (Patient Health Questionnaire; PHQ-9) and mortality.

Ethics and dissemination: This trial is approved by the CHU de Québec-Université Laval research ethics board (MP-20-2018-3706) and ethic boards at all participating sites. Our results will be published and shared with relevant organisations and healthcare professionals.

Trial registration number: NCT03260478.

Keywords: Adult intensive & critical care; INTENSIVE & CRITICAL CARE; Neurological injury; TRAUMA MANAGEMENT.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Blood Transfusion
Brain Injuries, Traumatic* / therapy
Erythrocyte Transfusion / methods
Hemoglobins / metabolism
Humans
Multicenter Studies as Topic
Quality of Life*
Randomized Controlled Trials as Topic

Substances

Hemoglobins

Associated data

ClinicalTrials.gov/NCT03260478