PT  - JOURNAL ARTICLE
AU  - Turgeon, Alexis F
AU  - Fergusson, Dean A
AU  - Clayton, Lucy
AU  - Patton, Marie-Pier
AU  - Zarychanski, Ryan
AU  - English, Shane
AU  - Docherty, Annemarie
AU  - Walsh, Timothy
AU  - Griesdale, Donald
AU  - Kramer, Andreas H
AU  - Scales, Damon
AU  - Burns, Karen E. A.
AU  - Boyd, John Gordon
AU  - Marshall, John C
AU  - Kutsogiannis, Demetrios J
AU  - Ball, Ian
AU  - Hébert, Paul C
AU  - Lamontagne, Francois
AU  - Costerousse, Olivier
AU  - St-Onge, Maude
AU  - Lessard Bonaventure, Paule
AU  - Moore, Lynne
AU  - Neveu, Xavier
AU  - Rigamonti, Andrea
AU  - Khwaja, Kosar
AU  - Green, Robert S
AU  - Laroche, Vincent
AU  - Fox-Robichaud, Alison
AU  - Lauzier, Francois
ED  - ,
TI  - Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol
AID  - 10.1136/bmjopen-2022-067117
DP  - 2022 Oct 01
TA  - BMJ Open
PG  - e067117
VI  - 12
IP  - 10
4099  - http://bmjopen.bmj.com/content/12/10/e067117.short
4100  - http://bmjopen.bmj.com/content/12/10/e067117.full
SO  - BMJ Open2022 Oct 01; 12
AB  - 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.