RT Journal Article
SR Electronic
T1 Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e067117
DO 10.1136/bmjopen-2022-067117
VO 12
IS 10
A1 Turgeon, Alexis F
A1 Fergusson, Dean A
A1 Clayton, Lucy
A1 Patton, Marie-Pier
A1 Zarychanski, Ryan
A1 English, Shane
A1 Docherty, Annemarie
A1 Walsh, Timothy
A1 Griesdale, Donald
A1 Kramer, Andreas H
A1 Scales, Damon
A1 Burns, Karen E. A.
A1 Boyd, John Gordon
A1 Marshall, John C
A1 Kutsogiannis, Demetrios J
A1 Ball, Ian
A1 Hébert, Paul C
A1 Lamontagne, Francois
A1 Costerousse, Olivier
A1 St-Onge, Maude
A1 Lessard Bonaventure, Paule
A1 Moore, Lynne
A1 Neveu, Xavier
A1 Rigamonti, Andrea
A1 Khwaja, Kosar
A1 Green, Robert S
A1 Laroche, Vincent
A1 Fox-Robichaud, Alison
A1 Lauzier, Francois
A1 ,
YR 2022
UL http://bmjopen.bmj.com/content/12/10/e067117.abstract
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.