Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol
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 t...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-10-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/10/e067117.full |
| _version_ | 1811337311035588608 |
|---|---|
| author | Robert S Green Dean A Fergusson Demetrios J Kutsogiannis Ryan Zarychanski Kosar Khwaja Donald Griesdale François Lauzier Alison Fox-Robichaud Ian Ball Alexis F Turgeon John Gordon Boyd Paul C Hébert Shane English Timothy Walsh Andreas H Kramer John C Marshall Damon Scales Olivier Costerousse Annemarie Docherty Andrea Rigamonti Maude St-Onge Lucy Clayton Marie-Pier Patton Karen E. A. Burns Paule Lessard Bonaventure Xavier Neveu Vincent Laroche |
| author_facet | Robert S Green Dean A Fergusson Demetrios J Kutsogiannis Ryan Zarychanski Kosar Khwaja Donald Griesdale François Lauzier Alison Fox-Robichaud Ian Ball Alexis F Turgeon John Gordon Boyd Paul C Hébert Shane English Timothy Walsh Andreas H Kramer John C Marshall Damon Scales Olivier Costerousse Annemarie Docherty Andrea Rigamonti Maude St-Onge Lucy Clayton Marie-Pier Patton Karen E. A. Burns Paule Lessard Bonaventure Xavier Neveu Vincent Laroche |
| author_sort | Robert S Green |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T17:52:06Z |
| format | Article |
| id | doaj.art-08d78388f188440695220058ef5266a2 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-13T17:52:06Z |
| publishDate | 2022-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-08d78388f188440695220058ef5266a22022-12-22T02:36:38ZengBMJ Publishing GroupBMJ Open2044-60552022-10-01121010.1136/bmjopen-2022-067117Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocolRobert S Green0Dean A Fergusson1Demetrios J Kutsogiannis2Ryan Zarychanski3Kosar Khwaja4Donald Griesdale5François Lauzier6Alison Fox-Robichaud7Ian Ball8Alexis F Turgeon9John Gordon Boyd10Paul C Hébert11Shane English12Timothy Walsh13Andreas H Kramer14John C Marshall15Damon Scales16Olivier Costerousse17Annemarie Docherty18Andrea Rigamonti19Maude St-Onge20Lucy Clayton21Marie-Pier Patton22Karen E. A. Burns23Paule Lessard Bonaventure24Xavier Neveu25Vincent Laroche26Departments of Emergency Medicine, Dalhousie University, Halifax, Nova Scotia, CanadaClinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaDepartment of Critical Care Medicine, University of Alberta, Edmonton, Alberta, CanadaDepartment of Internal Medicine, Section of Hematology/Oncology, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, CanadaDepartment of Critical Care Medicine, McGill University, Montréal, Québec, CanadaDepartment of Anesthesiology, Pharmacology, and Therapeutics, University of British Columbia, Vancouver, British Columbia, CanadaPopulation Health and Optimal Practices Research Unit (Trauma— Emergency—Critical Care Medicine), CHU de Québec-Universite Laval Research Center, Québec City, Québec, CanadaDepartment of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, CanadaDepartment of Medicine, Western University, London, Ontario, CanadaPopulation Health and Optimal Practices Research Unit (Trauma— Emergency—Critical Care Medicine), CHU de Québec-Universite Laval Research Center, Québec City, Québec, CanadaDepartment of Medicine, Division of Neurology, Queen`s University, Kingston, Ontario, CanadaDepartment of Medicine, Centre Hospitalier de l`Université de Montréal, Montréal, Québec, CanadaClinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaCentre for Medical Informatics, Usher Institute, The University of Edinburgh, Edinburgh, UKDepartment of Critical Care Medicine, Foothills Medical Center, University of Calgary, Calgary, Alberta, CanadaInterdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, CanadaInterdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, CanadaPopulation Health and Optimal Practices Research Unit (Trauma— Emergency—Critical Care Medicine), CHU de Québec-Universite Laval Research Center, Québec City, Québec, CanadaCentre for Medical Informatics, Usher Institute, The University of Edinburgh, Edinburgh, UKInterdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, CanadaPopulation Health and Optimal Practices Research Unit (Trauma— Emergency—Critical Care Medicine), CHU de Québec-Universite Laval Research Center, Québec City, Québec, CanadaPopulation Health and Optimal Practices Research Unit (Trauma— Emergency—Critical Care Medicine), CHU de Québec-Universite Laval Research Center, Québec City, Québec, CanadaPopulation Health and Optimal Practices Research Unit (Trauma— Emergency—Critical Care Medicine), CHU de Québec-Universite Laval Research Center, Québec City, Québec, CanadaInterdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, CanadaPopulation Health and Optimal Practices Research Unit (Trauma— Emergency—Critical Care Medicine), CHU de Québec-Universite Laval Research Center, Québec City, Québec, CanadaPopulation Health and Optimal Practices Research Unit (Trauma— Emergency—Critical Care Medicine), CHU de Québec-Universite Laval Research Center, Québec City, Québec, CanadaPopulation Health and Optimal Practices Research Unit (Trauma— Emergency—Critical Care Medicine), CHU de Québec-Universite Laval Research Center, Québec City, Québec, CanadaIntroduction 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.https://bmjopen.bmj.com/content/12/10/e067117.full |
| spellingShingle | Robert S Green Dean A Fergusson Demetrios J Kutsogiannis Ryan Zarychanski Kosar Khwaja Donald Griesdale François Lauzier Alison Fox-Robichaud Ian Ball Alexis F Turgeon John Gordon Boyd Paul C Hébert Shane English Timothy Walsh Andreas H Kramer John C Marshall Damon Scales Olivier Costerousse Annemarie Docherty Andrea Rigamonti Maude St-Onge Lucy Clayton Marie-Pier Patton Karen E. A. Burns Paule Lessard Bonaventure Xavier Neveu Vincent Laroche Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol BMJ Open |
| title | Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol |
| title_full | Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol |
| title_fullStr | Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol |
| title_full_unstemmed | Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol |
| title_short | Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol |
| title_sort | haemoglobin transfusion threshold in traumatic brain injury optimisation hemotion a multicentre randomised clinical trial protocol |
| url | https://bmjopen.bmj.com/content/12/10/e067117.full |
| work_keys_str_mv | AT robertsgreen haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT deanafergusson haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT demetriosjkutsogiannis haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT ryanzarychanski haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT kosarkhwaja haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT donaldgriesdale haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT francoislauzier haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT alisonfoxrobichaud haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT ianball haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT alexisfturgeon haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT johngordonboyd haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT paulchebert haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT shaneenglish haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT timothywalsh haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT andreashkramer haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT johncmarshall haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT damonscales haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT oliviercosterousse haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT annemariedocherty haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT andrearigamonti haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT maudestonge haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT lucyclayton haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT mariepierpatton haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT kareneaburns haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT paulelessardbonaventure haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT xavierneveu haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol AT vincentlaroche haemoglobintransfusionthresholdintraumaticbraininjuryoptimisationhemotionamulticentrerandomisedclinicaltrialprotocol |