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

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

Alexis F Turgeon  1   2 , Dean A Fergusson  3   4 , Lucy Clayton  5   6 , Marie-Pier Patton  5 , Ryan Zarychanski  7   8 , Shane English  3   4   9 , Annemarie Docherty  10 , Timothy Walsh  10 , Donald Griesdale  11   12   13 , Andreas H Kramer  14 , Damon Scales  15   16 , Karen E A Burns  15   17 , John Gordon Boyd  18   19 , John C Marshall  15   17   20 , Demetrios J Kutsogiannis  21 , Ian Ball  22   23 , Paul C Hébert  24 , Francois Lamontagne  25   26 , Olivier Costerousse  5 , Maude St-Onge  5   2   27 , Paule Lessard Bonaventure  5   28 , Lynne Moore  5   29 , Xavier Neveu  5 , Andrea Rigamonti  15   30 , Kosar Khwaja  31 , Robert S Green  32   33 , Vincent Laroche  5   34 , Alison Fox-Robichaud  35 , 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

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

Alexis F Turgeon et al. BMJ Open. .

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.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Flow diagram. GCS, Glasgow Coma Scale; Hb, haemoglobin; ICU, intensive care unit; TBI, traumatic brain injury.
Figure 2
Figure 2
Potential protocol deviations and violations. ICU, intensive care unit.
See this image and copyright information in PMC

References

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