Early diagnosis of mortality using admission CT perfusion in severe traumatic brain injury patients (ACT-TBI): protocol for a prospective cohort study
IntroductionSevere traumatic brain injury (TBI) is a catastrophic neurological condition with significant economic burden. Early in-hospital mortality (<48 hours) with severe TBI is estimated at 50%. Several clinical examinations exist to determine brain death; however, most are difficult to elic...
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Published in | BMJ open Vol. 11; no. 6; p. e047305 |
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Abstract | IntroductionSevere traumatic brain injury (TBI) is a catastrophic neurological condition with significant economic burden. Early in-hospital mortality (<48 hours) with severe TBI is estimated at 50%. Several clinical examinations exist to determine brain death; however, most are difficult to elicit in the acute setting in patients with severe TBI. Having a definitive assessment tool would help predict early in-hospital mortality in this population. CT perfusion (CTP) has shown promise diagnosing early in-hospital mortality in patients with severe TBI and other populations. The purpose of this study is to validate admission CTP features of brain death relative to the clinical examination outcome for characterizing early in-hospital mortality in patients with severe TBI.Methods and analysisThe Early Diagnosis of Mortality using Admission CT Perfusion in Severe Traumatic Brain Injury Patients study, is a prospective cohort study in patients with severe TBI funded by a grant from the Canadian Institute of Health Research. Adults aged 18 or older, with evidence of a severe TBI (Glasgow Coma Scale score ≤8 before initial resuscitation) and, on mechanical ventilation at the time of imaging are eligible. Patients will undergo CTP at the time of first imaging on their hospital admission. Admission CTP compares with the reference standard of an accepted bedside clinical assessment for brainstem function. Deferred consent will be used. The primary outcome is a binary outcome of mortality (dead) or survival (not dead) in the first 48 hours of admission. The planned sample size for achieving a sensitivity of 75% and a specificity of 95% with a CI of ±5% is 200 patients.Ethics and disseminationThis study has been approved by the University of Manitoba Health Research Ethics Board. The findings from our study will be disseminated through peer-reviewed journals and presentations at local rounds, national and international conferences. The public will be informed through forums at the end of the study.Trial registration numberNCT04318665 |
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AbstractList | INTRODUCTIONSevere traumatic brain injury (TBI) is a catastrophic neurological condition with significant economic burden. Early in-hospital mortality (<48 hours) with severe TBI is estimated at 50%. Several clinical examinations exist to determine brain death; however, most are difficult to elicit in the acute setting in patients with severe TBI. Having a definitive assessment tool would help predict early in-hospital mortality in this population. CT perfusion (CTP) has shown promise diagnosing early in-hospital mortality in patients with severe TBI and other populations. The purpose of this study is to validate admission CTP features of brain death relative to the clinical examination outcome for characterizing early in-hospital mortality in patients with severe TBI. METHODS AND ANALYSISThe Early Diagnosis of Mortality using Admission CT Perfusion in Severe Traumatic Brain Injury Patients study, is a prospective cohort study in patients with severe TBI funded by a grant from the Canadian Institute of Health Research. Adults aged 18 or older, with evidence of a severe TBI (Glasgow Coma Scale score ≤8 before initial resuscitation) and, on mechanical ventilation at the time of imaging are eligible. Patients will undergo CTP at the time of first imaging on their hospital admission. Admission CTP compares with the reference standard of an accepted bedside clinical assessment for brainstem function. Deferred consent will be used. The primary outcome is a binary outcome of mortality (dead) or survival (not dead) in the first 48 hours of admission. The planned sample size for achieving a sensitivity of 75% and a specificity of 95% with a CI of ±5% is 200 patients. ETHICS AND DISSEMINATIONThis study has been approved by the University of Manitoba Health Research Ethics Board. The findings from our study will be disseminated through peer-reviewed journals and presentations at local rounds, national and international conferences. The public will be informed through forums at the end of the study. TRIAL REGISTRATION NUMBERNCT04318665. IntroductionSevere traumatic brain injury (TBI) is a catastrophic neurological condition with significant economic burden. Early in-hospital mortality (<48 hours) with severe TBI is estimated at 50%. Several clinical examinations exist to determine brain death; however, most are difficult to elicit in the acute setting in patients with severe TBI. Having a definitive assessment tool would help predict early in-hospital mortality in this population. CT perfusion (CTP) has shown promise diagnosing early in-hospital mortality in patients with severe TBI and other populations. The purpose of this study is to validate admission CTP features of brain death relative to the clinical examination outcome for characterizing early in-hospital mortality in patients with severe TBI.Methods and analysisThe Early Diagnosis of Mortality using Admission CT Perfusion in Severe Traumatic Brain Injury Patients study, is a prospective cohort study in patients with severe TBI funded by a grant from the Canadian Institute of Health Research. Adults aged 18 or older, with evidence of a severe TBI (Glasgow Coma Scale score ≤8 before initial resuscitation) and, on mechanical ventilation at the time of imaging are eligible. Patients will undergo CTP at the time of first imaging on their hospital admission. Admission CTP compares with the reference standard of an accepted bedside clinical assessment for brainstem function. Deferred consent will be used. The primary outcome is a binary outcome of mortality (dead) or survival (not dead) in the first 48 hours of admission. The planned sample size for achieving a sensitivity of 75% and a specificity of 95% with a CI of ±5% is 200 patients.Ethics and disseminationThis study has been approved by the University of Manitoba Health Research Ethics Board. The findings from our study will be disseminated through peer-reviewed journals and presentations at local rounds, national and international conferences. The public will be informed through forums at the end of the study.Trial registration numberNCT04318665 Introduction Severe traumatic brain injury (TBI) is a catastrophic neurological condition with significant economic burden. Early in-hospital mortality (<48 hours) with severe TBI is estimated at 50%. Several clinical examinations exist to determine brain death; however, most are difficult to elicit in the acute setting in patients with severe TBI. Having a definitive assessment tool would help predict early in-hospital mortality in this population. CT perfusion (CTP) has shown promise diagnosing early in-hospital mortality in patients with severe TBI and other populations. The purpose of this study is to validate admission CTP features of brain death relative to the clinical examination outcome for characterizing early in-hospital mortality in patients with severe TBI.Methods and analysis The Early Diagnosis of Mortality using Admission CT Perfusion in Severe Traumatic Brain Injury Patients study, is a prospective cohort study in patients with severe TBI funded by a grant from the Canadian Institute of Health Research. Adults aged 18 or older, with evidence of a severe TBI (Glasgow Coma Scale score ≤8 before initial resuscitation) and, on mechanical ventilation at the time of imaging are eligible. Patients will undergo CTP at the time of first imaging on their hospital admission. Admission CTP compares with the reference standard of an accepted bedside clinical assessment for brainstem function. Deferred consent will be used. The primary outcome is a binary outcome of mortality (dead) or survival (not dead) in the first 48 hours of admission. The planned sample size for achieving a sensitivity of 75% and a specificity of 95% with a CI of ±5% is 200 patients.Ethics and dissemination This study has been approved by the University of Manitoba Health Research Ethics Board. The findings from our study will be disseminated through peer-reviewed journals and presentations at local rounds, national and international conferences. The public will be informed through forums at the end of the study.Trial registration number NCT04318665 Introduction Severe traumatic brain injury (TBI) is a catastrophic neurological condition with significant economic burden. Early in-hospital mortality (<48 hours) with severe TBI is estimated at 50%. Several clinical examinations exist to determine brain death; however, most are difficult to elicit in the acute setting in patients with severe TBI. Having a definitive assessment tool would help predict early in-hospital mortality in this population. CT perfusion (CTP) has shown promise diagnosing early in-hospital mortality in patients with severe TBI and other populations. The purpose of this study is to validate admission CTP features of brain death relative to the clinical examination outcome for characterizing early in-hospital mortality in patients with severe TBI. Methods and analysis The Early Diagnosis of Mortality using Admission CT Perfusion in Severe Traumatic Brain Injury Patients study, is a prospective cohort study in patients with severe TBI funded by a grant from the Canadian Institute of Health Research. Adults aged 18 or older, with evidence of a severe TBI (Glasgow Coma Scale score ≤8 before initial resuscitation) and, on mechanical ventilation at the time of imaging are eligible. Patients will undergo CTP at the time of first imaging on their hospital admission. Admission CTP compares with the reference standard of an accepted bedside clinical assessment for brainstem function. Deferred consent will be used. The primary outcome is a binary outcome of mortality (dead) or survival (not dead) in the first 48 hours of admission. The planned sample size for achieving a sensitivity of 75% and a specificity of 95% with a CI of ±5% is 200 patients. Ethics and dissemination This study has been approved by the University of Manitoba Health Research Ethics Board. The findings from our study will be disseminated through peer-reviewed journals and presentations at local rounds, national and international conferences. The public will be informed through forums at the end of the study. Trial registration number NCT04318665 |
Author | Alcock, Susan Batoo, Divjeet Grierson, Rob Leeies, Murdoch Zeiler, Frederick A Martin, Douglas Shankar, Jai Jai Shiva Ande, Sudharsana Rao Trivedi, Anurag Essig, Marco Sinha, Namita |
AuthorAffiliation | 4 Section of Neuropathology, Department of Pathology , University of Manitoba Faculty of Health Sciences , Winnipeg , Manitoba , Canada 1 Department of Radiology , University of Manitoba Faculty of Health Sciences , Winnipeg , Manitoba , Canada 2 Department of Emergency Medicine , University of Manitoba Faculty of Health Sciences , Winnipeg , Manitoba , Canada 7 Department of Human Anatomy and Cell Science , University of Manitoba Faculty of Health Sciences , Winnipeg , Manitoba , Canada 3 Section of Neurology, Department of Internal Medicine , University of Manitoba Faculty of Health Sciences , Winnipeg , Manitoba , Canada 5 Department of Emergency Medicine & Section of Critical Care Medicine , University of Manitoba Faculty of Health Sciences , Winnipeg , Manitoba , Canada 6 Section of Neurosurgery, Department of Surgery , University of Manitoba Faculty of Health Sciences , Winnipeg , Manitoba , Canada |
AuthorAffiliation_xml | – name: 2 Department of Emergency Medicine , University of Manitoba Faculty of Health Sciences , Winnipeg , Manitoba , Canada – name: 4 Section of Neuropathology, Department of Pathology , University of Manitoba Faculty of Health Sciences , Winnipeg , Manitoba , Canada – name: 7 Department of Human Anatomy and Cell Science , University of Manitoba Faculty of Health Sciences , Winnipeg , Manitoba , Canada – name: 3 Section of Neurology, Department of Internal Medicine , University of Manitoba Faculty of Health Sciences , Winnipeg , Manitoba , Canada – name: 5 Department of Emergency Medicine & Section of Critical Care Medicine , University of Manitoba Faculty of Health Sciences , Winnipeg , Manitoba , Canada – name: 1 Department of Radiology , University of Manitoba Faculty of Health Sciences , Winnipeg , Manitoba , Canada – name: 6 Section of Neurosurgery, Department of Surgery , University of Manitoba Faculty of Health Sciences , Winnipeg , Manitoba , Canada |
Author_xml | – sequence: 1 givenname: Susan surname: Alcock fullname: Alcock, Susan email: shivajai1@gmail.com organization: Department of Radiology, University of Manitoba Faculty of Health Sciences, Winnipeg, Manitoba, Canada – sequence: 2 givenname: Divjeet surname: Batoo fullname: Batoo, Divjeet email: shivajai1@gmail.com organization: Department of Radiology, University of Manitoba Faculty of Health Sciences, Winnipeg, Manitoba, Canada – sequence: 3 givenname: Sudharsana Rao surname: Ande fullname: Ande, Sudharsana Rao email: shivajai1@gmail.com organization: Department of Radiology, University of Manitoba Faculty of Health Sciences, Winnipeg, Manitoba, Canada – sequence: 4 givenname: Rob surname: Grierson fullname: Grierson, Rob email: shivajai1@gmail.com organization: Department of Emergency Medicine, University of Manitoba Faculty of Health Sciences, Winnipeg, Manitoba, Canada – sequence: 5 givenname: Marco surname: Essig fullname: Essig, Marco email: shivajai1@gmail.com organization: Department of Radiology, University of Manitoba Faculty of Health Sciences, Winnipeg, Manitoba, Canada – sequence: 6 givenname: Douglas surname: Martin fullname: Martin, Douglas email: shivajai1@gmail.com organization: Department of Emergency Medicine, University of Manitoba Faculty of Health Sciences, Winnipeg, Manitoba, Canada – sequence: 7 givenname: Anurag surname: Trivedi fullname: Trivedi, Anurag email: shivajai1@gmail.com organization: Section of Neurology, Department of Internal Medicine, University of Manitoba Faculty of Health Sciences, Winnipeg, Manitoba, Canada – sequence: 8 givenname: Namita surname: Sinha fullname: Sinha, Namita email: shivajai1@gmail.com organization: Section of Neuropathology, Department of Pathology, University of Manitoba Faculty of Health Sciences, Winnipeg, Manitoba, Canada – sequence: 9 givenname: Murdoch surname: Leeies fullname: Leeies, Murdoch email: shivajai1@gmail.com organization: Department of Emergency Medicine & Section of Critical Care Medicine, University of Manitoba Faculty of Health Sciences, Winnipeg, Manitoba, Canada – sequence: 10 givenname: Frederick A orcidid: 0000-0003-1737-0510 surname: Zeiler fullname: Zeiler, Frederick A email: shivajai1@gmail.com organization: Department of Human Anatomy and Cell Science, University of Manitoba Faculty of Health Sciences, Winnipeg, Manitoba, Canada – sequence: 11 givenname: Jai Jai Shiva orcidid: 0000-0002-3707-9723 surname: Shankar fullname: Shankar, Jai Jai Shiva email: shivajai1@gmail.com organization: Department of Human Anatomy and Cell Science, University of Manitoba Faculty of Health Sciences, Winnipeg, Manitoba, Canada |
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Snippet | IntroductionSevere traumatic brain injury (TBI) is a catastrophic neurological condition with significant economic burden. Early in-hospital mortality (<48... Introduction Severe traumatic brain injury (TBI) is a catastrophic neurological condition with significant economic burden. Early in-hospital mortality (<48... INTRODUCTIONSevere traumatic brain injury (TBI) is a catastrophic neurological condition with significant economic burden. Early in-hospital mortality (<48... Introduction Severe traumatic brain injury (TBI) is a catastrophic neurological condition with significant economic burden. Early in-hospital mortality (<48... |
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SubjectTerms | Blood & organ donations Brain death Brain research Cohort analysis Critical care Emergency medical care Health sciences Hospitals Medical diagnosis Medicin och hälsovetenskap Mortality Neurosurgery Patients Radiology and Imaging Trauma Traumatic brain injury |
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Title | Early diagnosis of mortality using admission CT perfusion in severe traumatic brain injury patients (ACT-TBI): protocol for a prospective cohort study |
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