Statistical analysis plan for the Erythropoietin in Traumatic Brain Injury trial: a randomised controlled trial of erythropoietin versus placebo in moderate and severe traumatic brain injury
Identifieur interne : 000D14 ( Pmc/Curation ); précédent : 000D13; suivant : 000D15Statistical analysis plan for the Erythropoietin in Traumatic Brain Injury trial: a randomised controlled trial of erythropoietin versus placebo in moderate and severe traumatic brain injury
Auteurs : Jeffrey Presneill [Australie] ; Lorraine Little [Australie] ; Alistair Nichol [Australie, Irlande (pays)] ; Craig French [Australie] ; D James Cooper [Australie] ; Samir Haddad [Australie] ; Jacques Duranteau [Australie] ; Olivier Huet [France] ; Markus Skrifvars ; Yaseen Arabi [Australie] ; Rinaldo Bellomo [Australie]Source :
- Trials [ 1745-6215 ] ; 2014.
Abstract
The Erythropoietin in Traumatic Brain Injury (EPO-TBI) trial aims to determine whether the administration of erythropoietin to patients with moderate or severe traumatic brain injury improves patient-centred outcomes.
EPO-TBI is a multicentre, blinded, randomised, parallel groups, placebo-controlled, phase III superiority trial of erythropoietin in ICU patients with traumatic brain injury conducted in Australia and New Zealand, Saudi Arabia and Europe; 606 critically ill patients aged 15 to 65 years with moderate or severe acute traumatic brain injury will be enrolled.
Trial patients will receive either 40,000 IU erythropoietin or placebo by subcutaneous injection administered weekly for up to three doses during their ICU admission.
The primary outcome measure is the proportion of unfavourable neurological outcomes, comprising death or severe disability, observed at 6 months following randomisation utilizing the Extended Glasgow Outcome Scale. Secondary outcomes, also assessed at 6 months following randomisation, include the probability of an equal or greater Extended Glasgow Outcome Scale level, mortality, the proportions of patients with proximal deep venous thrombosis or with composite thrombotic vascular events, as well as assessment of quality of life and cost-effectiveness. The planned sample size will allow 90% power to detect a reduction from 50% to 36% in unfavourable neurological outcomes at a two-sided alpha of 0.05.
A detailed analysis plan has been developed for EPO-TBI that is consistent with international guidelines. This plan specifies the statistical models for evaluation of primary and secondary outcomes, as well as defining covariates for adjusted analyses.
Application of this statistical analysis plan to the forthcoming EPO-TBI trial will facilitate unbiased analyses of these important clinical data.
Australian New Zealand Clinical Trials Registry:
The online version of this article (doi:10.1186/1745-6215-15-501) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1186/1745-6215-15-501
PubMed: 25528574
PubMed Central: 4414377
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Samir Haddad<affiliation><nlm:aff id="Aff92">Intensive Care Department, King Abdulaziz Medical City, PO Box 22490, Riyadh, 11426 Kingdom of Saudi Arabia</nlm:aff><wicri:noCountry code="subfield">11426 Kingdom of Saudi Arabia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff93">Service d’Anesthésie-Réanimation, Hôpitaux universitaires Paris Sud, Assistance Publique des Hôpitaux de Paris, Hôpital de Bicêtre, 78, rue du Général Leclerc, Paris, 94275 Le Kremlin Bicêtre France</nlm:aff><wicri:noCountry code="subfield">94275 Le Kremlin Bicêtre France</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff95">Department of Anaesthesiology and Intensive Care Medicine, Helsinki University Hospital, P.O. Box 266, Helsinki, FIN-00029 Finland</nlm:aff><wicri:noCountry code="subfield">FIN-00029 Finland</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff96">Intensive Care Department, College of Medicine King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, PO Box 22490, Riyadh, 11426 Kingdom of Saudi Arabia</nlm:aff><wicri:noCountry code="subfield">11426 Kingdom of Saudi Arabia</wicri:noCountry></affiliation>Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Statistical analysis plan for the Erythropoietin in Traumatic Brain Injury trial: a randomised controlled trial of erythropoietin versus placebo in moderate and severe traumatic brain injury</title><author><name sortKey="Presneill, Jeffrey" sort="Presneill, Jeffrey" uniqKey="Presneill J" first="Jeffrey" last="Presneill">Jeffrey Presneill</name><affiliation wicri:level="1"><nlm:aff id="Aff85">Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff86">Department of Intensive Care, Mater Health Services, Raymond 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id="Aff91">The University of Melbourne, Grattan Street, Parkville, 3052 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>The University of Melbourne, Grattan Street, Parkville</wicri:regionArea></affiliation></author><author><name sortKey="Cooper, D James" sort="Cooper, D James" uniqKey="Cooper D" first="D James" last="Cooper">D James Cooper</name><affiliation wicri:level="1"><nlm:aff id="Aff85">Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff89">Department of Intensive Care Medicine, The Alfred, Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Intensive Care Medicine, The Alfred, Commercial Road, Melbourne</wicri:regionArea></affiliation></author><author><name sortKey="Haddad, Samir" sort="Haddad, Samir" uniqKey="Haddad S" first="Samir" last="Haddad">Samir Haddad</name><affiliation wicri:level="1"><nlm:aff id="Aff85">Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne</wicri:regionArea></affiliation><affiliation><nlm:aff id="Aff92">Intensive Care Department, King Abdulaziz Medical City, PO Box 22490, Riyadh, 11426 Kingdom of Saudi Arabia</nlm:aff><wicri:noCountry code="subfield">11426 Kingdom of Saudi Arabia</wicri:noCountry></affiliation></author><author><name sortKey="Duranteau, Jacques" sort="Duranteau, Jacques" uniqKey="Duranteau J" first="Jacques" last="Duranteau">Jacques Duranteau</name><affiliation wicri:level="1"><nlm:aff id="Aff85">Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne</wicri:regionArea></affiliation><affiliation><nlm:aff id="Aff93">Service d’Anesthésie-Réanimation, Hôpitaux universitaires Paris Sud, Assistance Publique des Hôpitaux de Paris, Hôpital de Bicêtre, 78, rue du Général Leclerc, Paris, 94275 Le Kremlin Bicêtre France</nlm:aff><wicri:noCountry code="subfield">94275 Le Kremlin Bicêtre France</wicri:noCountry></affiliation></author><author><name sortKey="Huet, Olivier" sort="Huet, Olivier" uniqKey="Huet O" first="Olivier" last="Huet">Olivier Huet</name><affiliation wicri:level="1"><nlm:aff id="Aff94">Department of Anesthesiology and Intensive Care Medicine, CHRU La Cavale Blanche Université de Bretagne Ouest, Brest, Cedex, 29609 France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Department of Anesthesiology and Intensive Care Medicine, CHRU La Cavale Blanche Université de Bretagne Ouest, Brest, Cedex</wicri:regionArea></affiliation></author><author><name sortKey="Skrifvars, Markus" sort="Skrifvars, Markus" uniqKey="Skrifvars M" first="Markus" last="Skrifvars">Markus Skrifvars</name><affiliation><nlm:aff id="Aff95">Department of Anaesthesiology and Intensive Care Medicine, Helsinki University Hospital, P.O. Box 266, Helsinki, FIN-00029 Finland</nlm:aff><wicri:noCountry code="subfield">FIN-00029 Finland</wicri:noCountry></affiliation></author><author><name sortKey="Arabi, Yaseen" sort="Arabi, Yaseen" uniqKey="Arabi Y" first="Yaseen" last="Arabi">Yaseen Arabi</name><affiliation wicri:level="1"><nlm:aff id="Aff85">Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne</wicri:regionArea></affiliation><affiliation><nlm:aff id="Aff96">Intensive Care Department, College of Medicine King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, PO Box 22490, Riyadh, 11426 Kingdom of Saudi Arabia</nlm:aff><wicri:noCountry code="subfield">11426 Kingdom of Saudi Arabia</wicri:noCountry></affiliation></author><author><name sortKey="Bellomo, Rinaldo" sort="Bellomo, Rinaldo" uniqKey="Bellomo R" first="Rinaldo" last="Bellomo">Rinaldo Bellomo</name><affiliation wicri:level="1"><nlm:aff id="Aff85">Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff91">The University of Melbourne, Grattan Street, Parkville, 3052 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>The University of Melbourne, Grattan Street, Parkville</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff97">Department of Intensive Care, Austin Health, Studley Road, Heidelberg, 3084 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Intensive Care, Austin Health, Studley Road, Heidelberg</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25528574</idno><idno type="pmc">4414377</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4414377</idno><idno type="RBID">PMC:4414377</idno><idno type="doi">10.1186/1745-6215-15-501</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">000E53</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000E53</idno><idno type="wicri:Area/Pmc/Curation">000D14</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000D14</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Statistical analysis plan for the Erythropoietin in Traumatic Brain Injury trial: a randomised controlled trial of erythropoietin versus placebo in moderate and severe traumatic brain injury</title><author><name sortKey="Presneill, Jeffrey" sort="Presneill, Jeffrey" uniqKey="Presneill J" first="Jeffrey" last="Presneill">Jeffrey Presneill</name><affiliation wicri:level="1"><nlm:aff id="Aff85">Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff86">Department of Intensive Care, Mater Health Services, Raymond Terrace, South Brisbane, 4101 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Intensive Care, Mater Health Services, Raymond Terrace, South Brisbane</wicri:regionArea></affiliation></author><author><name sortKey="Little, Lorraine" sort="Little, Lorraine" uniqKey="Little L" first="Lorraine" last="Little">Lorraine Little</name><affiliation wicri:level="1"><nlm:aff id="Aff85">Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne</wicri:regionArea></affiliation></author><author><name sortKey="Nichol, Alistair" sort="Nichol, Alistair" uniqKey="Nichol A" first="Alistair" last="Nichol">Alistair Nichol</name><affiliation wicri:level="1"><nlm:aff id="Aff85">Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff87">Department of Anaesthesia and Intensive Care Medicine, St Vincent’s University Hospital, Elm Park, Dublin 4, Ireland</nlm:aff><country xml:lang="fr">Irlande (pays)</country><wicri:regionArea>Department of Anaesthesia and Intensive Care Medicine, St Vincent’s University Hospital, Elm Park, Dublin 4</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff88">School of Medicine and Medical Sciences, University College, Elm Park, Dublin 4, Ireland</nlm:aff><country xml:lang="fr">Irlande (pays)</country><wicri:regionArea>School of Medicine and Medical Sciences, University College, Elm Park, Dublin 4</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff89">Department of Intensive Care Medicine, The Alfred, Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Intensive Care Medicine, The Alfred, Commercial Road, Melbourne</wicri:regionArea></affiliation></author><author><name sortKey="French, Craig" sort="French, Craig" uniqKey="French C" first="Craig" last="French">Craig French</name><affiliation wicri:level="1"><nlm:aff id="Aff90">Department of Intensive Care, Western Health, Gordon Street, Footscray, 3011 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Intensive Care, Western Health, Gordon Street, Footscray</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff91">The University of Melbourne, Grattan Street, Parkville, 3052 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>The University of Melbourne, Grattan Street, Parkville</wicri:regionArea></affiliation></author><author><name sortKey="Cooper, D James" sort="Cooper, D James" uniqKey="Cooper D" first="D James" last="Cooper">D James Cooper</name><affiliation wicri:level="1"><nlm:aff id="Aff85">Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff89">Department of Intensive Care Medicine, The Alfred, Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Intensive Care Medicine, The Alfred, Commercial Road, Melbourne</wicri:regionArea></affiliation></author><author><name sortKey="Haddad, Samir" sort="Haddad, Samir" uniqKey="Haddad S" first="Samir" last="Haddad">Samir Haddad</name><affiliation wicri:level="1"><nlm:aff id="Aff85">Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne</wicri:regionArea></affiliation><affiliation><nlm:aff id="Aff92">Intensive Care Department, King Abdulaziz Medical City, PO Box 22490, Riyadh, 11426 Kingdom of Saudi Arabia</nlm:aff><wicri:noCountry code="subfield">11426 Kingdom of Saudi Arabia</wicri:noCountry></affiliation></author><author><name sortKey="Duranteau, Jacques" sort="Duranteau, Jacques" uniqKey="Duranteau J" first="Jacques" last="Duranteau">Jacques Duranteau</name><affiliation wicri:level="1"><nlm:aff id="Aff85">Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne</wicri:regionArea></affiliation><affiliation><nlm:aff id="Aff93">Service d’Anesthésie-Réanimation, Hôpitaux universitaires Paris Sud, Assistance Publique des Hôpitaux de Paris, Hôpital de Bicêtre, 78, rue du Général Leclerc, Paris, 94275 Le Kremlin Bicêtre France</nlm:aff><wicri:noCountry code="subfield">94275 Le Kremlin Bicêtre France</wicri:noCountry></affiliation></author><author><name sortKey="Huet, Olivier" sort="Huet, Olivier" uniqKey="Huet O" first="Olivier" last="Huet">Olivier Huet</name><affiliation wicri:level="1"><nlm:aff id="Aff94">Department of Anesthesiology and Intensive Care Medicine, CHRU La Cavale Blanche Université de Bretagne Ouest, Brest, Cedex, 29609 France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Department of Anesthesiology and Intensive Care Medicine, CHRU La Cavale Blanche Université de Bretagne Ouest, Brest, Cedex</wicri:regionArea></affiliation></author><author><name sortKey="Skrifvars, Markus" sort="Skrifvars, Markus" uniqKey="Skrifvars M" first="Markus" last="Skrifvars">Markus Skrifvars</name><affiliation><nlm:aff id="Aff95">Department of Anaesthesiology and Intensive Care Medicine, Helsinki University Hospital, P.O. Box 266, Helsinki, FIN-00029 Finland</nlm:aff><wicri:noCountry code="subfield">FIN-00029 Finland</wicri:noCountry></affiliation></author><author><name sortKey="Arabi, Yaseen" sort="Arabi, Yaseen" uniqKey="Arabi Y" first="Yaseen" last="Arabi">Yaseen Arabi</name><affiliation wicri:level="1"><nlm:aff id="Aff85">Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne</wicri:regionArea></affiliation><affiliation><nlm:aff id="Aff96">Intensive Care Department, College of Medicine King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, PO Box 22490, Riyadh, 11426 Kingdom of Saudi Arabia</nlm:aff><wicri:noCountry code="subfield">11426 Kingdom of Saudi Arabia</wicri:noCountry></affiliation></author><author><name sortKey="Bellomo, Rinaldo" sort="Bellomo, Rinaldo" uniqKey="Bellomo R" first="Rinaldo" last="Bellomo">Rinaldo Bellomo</name><affiliation wicri:level="1"><nlm:aff id="Aff85">Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff91">The University of Melbourne, Grattan Street, Parkville, 3052 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>The University of Melbourne, Grattan Street, Parkville</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff97">Department of Intensive Care, Austin Health, Studley Road, Heidelberg, 3084 Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Intensive Care, Austin Health, Studley Road, Heidelberg</wicri:regionArea></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>The Erythropoietin in Traumatic Brain Injury (EPO-TBI) trial aims to determine whether the administration of erythropoietin to patients with moderate or severe traumatic brain injury improves patient-centred outcomes.</p></sec><sec><title>Methods</title><p>EPO-TBI is a multicentre, blinded, randomised, parallel groups, placebo-controlled, phase III superiority trial of erythropoietin in ICU patients with traumatic brain injury conducted in Australia and New Zealand, Saudi Arabia and Europe; 606 critically ill patients aged 15 to 65 years with moderate or severe acute traumatic brain injury will be enrolled.</p><p>Trial patients will receive either 40,000 IU erythropoietin or placebo by subcutaneous injection administered weekly for up to three doses during their ICU admission.</p><p>The primary outcome measure is the proportion of unfavourable neurological outcomes, comprising death or severe disability, observed at 6 months following randomisation utilizing the Extended Glasgow Outcome Scale. Secondary outcomes, also assessed at 6 months following randomisation, include the probability of an equal or greater Extended Glasgow Outcome Scale level, mortality, the proportions of patients with proximal deep venous thrombosis or with composite thrombotic vascular events, as well as assessment of quality of life and cost-effectiveness. The planned sample size will allow 90% power to detect a reduction from 50% to 36% in unfavourable neurological outcomes at a two-sided alpha of 0.05.</p></sec><sec><title>Discussion</title><p>A detailed analysis plan has been developed for EPO-TBI that is consistent with international guidelines. This plan specifies the statistical models for evaluation of primary and secondary outcomes, as well as defining covariates for adjusted analyses.</p><p>Application of this statistical analysis plan to the forthcoming EPO-TBI trial will facilitate unbiased analyses of these important clinical data.</p></sec><sec><title>Trial registration</title><p>Australian New Zealand Clinical Trials Registry: <ext-link ext-link-type="uri" xlink:href="http://www.anzctr.org.au/ACTRN12609000827235">ACTRN12609000827235</ext-link> (22 September 2009). ClinicalTrials.gov: <ext-link ext-link-type="uri" xlink:href="http://www.anzctr.org.au/">NCT00987454</ext-link> (29 September 2009). European Drug Regulatory Authorities Clinical Trials: 2011-005235-22 (18 January 2012).</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1186/1745-6215-15-501) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Nichol, Ad" uniqKey="Nichol A">AD Nichol</name></author><author><name sortKey="Higgins, Am" uniqKey="Higgins A">AM Higgins</name></author><author><name sortKey="Gabbe, Bj" uniqKey="Gabbe B">BJ Gabbe</name></author><author><name sortKey="Murray, Lj" uniqKey="Murray L">LJ Murray</name></author><author><name sortKey="Cooper, Dj" uniqKey="Cooper D">DJ Cooper</name></author><author><name sortKey="Cameron, Pa" uniqKey="Cameron P">PA Cameron</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Myburgh, Ja" uniqKey="Myburgh J">JA Myburgh</name></author><author><name sortKey="Cooper, Dj" uniqKey="Cooper D">DJ Cooper</name></author><author><name sortKey="Finfer, Sr" uniqKey="Finfer S">SR Finfer</name></author><author><name sortKey="Venkatesh, B" uniqKey="Venkatesh B">B Venkatesh</name></author><author><name sortKey="Jones, D" uniqKey="Jones D">D Jones</name></author><author><name sortKey="Higgins, A" uniqKey="Higgins A">A Higgins</name></author><author><name sortKey="Bishop, N" uniqKey="Bishop N">N Bishop</name></author><author><name sortKey="Higlett, T" uniqKey="Higlett T">T Higlett</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Moore, Em" uniqKey="Moore E">EM Moore</name></author><author><name sortKey="Bellomo, R" uniqKey="Bellomo R">R Bellomo</name></author><author><name sortKey="Nichol, Ad" uniqKey="Nichol A">AD Nichol</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Nichol, Ad" uniqKey="Nichol A">AD Nichol</name></author><author><name sortKey="Cooper, Dj" uniqKey="Cooper 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Grambsch</name></author><author><name sortKey="Therneau, Tm" uniqKey="Therneau T">TM Therneau</name></author></analytic></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Trials</journal-id><journal-id journal-id-type="iso-abbrev">Trials</journal-id><journal-title-group><journal-title>Trials</journal-title></journal-title-group><issn pub-type="epub">1745-6215</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">25528574</article-id><article-id pub-id-type="pmc">4414377</article-id><article-id pub-id-type="publisher-id">2416</article-id><article-id pub-id-type="doi">10.1186/1745-6215-15-501</article-id><article-categories><subj-group subj-group-type="heading"><subject>Update</subject></subj-group></article-categories><title-group><article-title>Statistical analysis plan for the Erythropoietin in Traumatic Brain Injury trial: a randomised controlled trial of erythropoietin versus placebo in moderate and severe traumatic brain injury</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Presneill</surname><given-names>Jeffrey</given-names></name><address><email>intensive@fastmail.com.au</email></address><xref ref-type="aff" rid="Aff85"></xref><xref ref-type="aff" rid="Aff86"></xref></contrib><contrib contrib-type="author"><name><surname>Little</surname><given-names>Lorraine</given-names></name><address><email>lorraine.little@monash.edu</email></address><xref ref-type="aff" rid="Aff85"></xref></contrib><contrib contrib-type="author"><name><surname>Nichol</surname><given-names>Alistair</given-names></name><address><email>alistair.nichol@monash.edu</email></address><xref ref-type="aff" rid="Aff85"></xref><xref ref-type="aff" rid="Aff87"></xref><xref ref-type="aff" rid="Aff88"></xref><xref ref-type="aff" rid="Aff89"></xref></contrib><contrib contrib-type="author"><name><surname>French</surname><given-names>Craig</given-names></name><address><email>craig.french@wh.org.au</email></address><xref ref-type="aff" rid="Aff90"></xref><xref ref-type="aff" rid="Aff91"></xref></contrib><contrib contrib-type="author"><name><surname>Cooper</surname><given-names>D James</given-names></name><address><email>jamie.cooper@monash.edu</email></address><xref ref-type="aff" rid="Aff85"></xref><xref ref-type="aff" rid="Aff89"></xref></contrib><contrib contrib-type="author"><name><surname>Haddad</surname><given-names>Samir</given-names></name><address><email>haddads55@yahoo.com</email></address><xref ref-type="aff" rid="Aff85"></xref><xref ref-type="aff" rid="Aff92"></xref></contrib><contrib contrib-type="author"><name><surname>Duranteau</surname><given-names>Jacques</given-names></name><address><email>jacques.duranteau@bct.aphp.fr</email></address><xref ref-type="aff" rid="Aff85"></xref><xref ref-type="aff" rid="Aff93"></xref></contrib><contrib contrib-type="author"><name><surname>Huet</surname><given-names>Olivier</given-names></name><address><email>olivier.huet@chu-brest.fr</email></address><xref ref-type="aff" rid="Aff94"></xref></contrib><contrib contrib-type="author"><name><surname>Skrifvars</surname><given-names>Markus</given-names></name><address><email>Markus.Skrifvars@hus.fi</email></address><xref ref-type="aff" rid="Aff95"></xref></contrib><contrib contrib-type="author"><name><surname>Arabi</surname><given-names>Yaseen</given-names></name><address><email>Arabi@NGHA.MED.SA</email></address><xref ref-type="aff" rid="Aff85"></xref><xref ref-type="aff" rid="Aff96"></xref></contrib><contrib contrib-type="author" corresp="yes"><name><surname>Bellomo</surname><given-names>Rinaldo</given-names></name><address><email>Rinaldo.Bellomo@austin.org.au</email></address><xref ref-type="aff" rid="Aff85"></xref><xref ref-type="aff" rid="Aff91"></xref><xref ref-type="aff" rid="Aff97"></xref></contrib><contrib contrib-type="author"><collab>on behalf of the EPO-TBI Investigators and the ANZICS Clinical Trials Group</collab></contrib><aff id="Aff85"><label></label>Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, 99 Commercial Road, Melbourne, 3004 Australia</aff><aff id="Aff86"><label></label>Department of Intensive Care, Mater Health Services, Raymond Terrace, South Brisbane, 4101 Australia</aff><aff id="Aff87"><label></label>Department of Anaesthesia and Intensive Care Medicine, St Vincent’s University Hospital, Elm Park, Dublin 4, Ireland</aff><aff id="Aff88"><label></label>School of Medicine and Medical Sciences, University College, Elm Park, Dublin 4, Ireland</aff><aff id="Aff89"><label></label>Department of Intensive Care Medicine, The Alfred, Commercial Road, Melbourne, 3004 Australia</aff><aff id="Aff90"><label></label>Department of Intensive Care, Western Health, Gordon Street, Footscray, 3011 Australia</aff><aff id="Aff91"><label></label>The University of Melbourne, Grattan Street, Parkville, 3052 Australia</aff><aff id="Aff92"><label></label>Intensive Care Department, King Abdulaziz Medical City, PO Box 22490, Riyadh, 11426 Kingdom of Saudi Arabia</aff><aff id="Aff93"><label></label>Service d’Anesthésie-Réanimation, Hôpitaux universitaires Paris Sud, Assistance Publique des Hôpitaux de Paris, Hôpital de Bicêtre, 78, rue du Général Leclerc, Paris, 94275 Le Kremlin Bicêtre France</aff><aff id="Aff94"><label></label>Department of Anesthesiology and Intensive Care Medicine, CHRU La Cavale Blanche Université de Bretagne Ouest, Brest, Cedex, 29609 France</aff><aff id="Aff95"><label></label>Department of Anaesthesiology and Intensive Care Medicine, Helsinki University Hospital, P.O. Box 266, Helsinki, FIN-00029 Finland</aff><aff id="Aff96"><label></label>Intensive Care Department, College of Medicine King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, PO Box 22490, Riyadh, 11426 Kingdom of Saudi Arabia</aff><aff id="Aff97"><label></label>Department of Intensive Care, Austin Health, Studley Road, Heidelberg, 3084 Australia</aff></contrib-group><pub-date pub-type="epub"><day>20</day><month>12</month><year>2014</year></pub-date><pub-date pub-type="pmc-release"><day>20</day><month>12</month><year>2014</year></pub-date><pub-date pub-type="collection"><year>2014</year></pub-date><volume>15</volume><elocation-id>501</elocation-id><history><date date-type="received"><day>19</day><month>9</month><year>2014</year></date><date date-type="accepted"><day>27</day><month>11</month><year>2014</year></date></history><permissions><copyright-statement>© Presneill et al.; licensee BioMed Central. 2014</copyright-statement><license license-type="open-access"><license-p>This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0">http://creativecommons.org/licenses/by/4.0</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>) applies to the data made available in this article, unless otherwise stated.</license-p></license></permissions><abstract id="Abs1"><sec><title>Background</title><p>The Erythropoietin in Traumatic Brain Injury (EPO-TBI) trial aims to determine whether the administration of erythropoietin to patients with moderate or severe traumatic brain injury improves patient-centred outcomes.</p></sec><sec><title>Methods</title><p>EPO-TBI is a multicentre, blinded, randomised, parallel groups, placebo-controlled, phase III superiority trial of erythropoietin in ICU patients with traumatic brain injury conducted in Australia and New Zealand, Saudi Arabia and Europe; 606 critically ill patients aged 15 to 65 years with moderate or severe acute traumatic brain injury will be enrolled.</p><p>Trial patients will receive either 40,000 IU erythropoietin or placebo by subcutaneous injection administered weekly for up to three doses during their ICU admission.</p><p>The primary outcome measure is the proportion of unfavourable neurological outcomes, comprising death or severe disability, observed at 6 months following randomisation utilizing the Extended Glasgow Outcome Scale. Secondary outcomes, also assessed at 6 months following randomisation, include the probability of an equal or greater Extended Glasgow Outcome Scale level, mortality, the proportions of patients with proximal deep venous thrombosis or with composite thrombotic vascular events, as well as assessment of quality of life and cost-effectiveness. The planned sample size will allow 90% power to detect a reduction from 50% to 36% in unfavourable neurological outcomes at a two-sided alpha of 0.05.</p></sec><sec><title>Discussion</title><p>A detailed analysis plan has been developed for EPO-TBI that is consistent with international guidelines. This plan specifies the statistical models for evaluation of primary and secondary outcomes, as well as defining covariates for adjusted analyses.</p><p>Application of this statistical analysis plan to the forthcoming EPO-TBI trial will facilitate unbiased analyses of these important clinical data.</p></sec><sec><title>Trial registration</title><p>Australian New Zealand Clinical Trials Registry: <ext-link ext-link-type="uri" xlink:href="http://www.anzctr.org.au/ACTRN12609000827235">ACTRN12609000827235</ext-link> (22 September 2009). ClinicalTrials.gov: <ext-link ext-link-type="uri" xlink:href="http://www.anzctr.org.au/">NCT00987454</ext-link> (29 September 2009). European Drug Regulatory Authorities Clinical Trials: 2011-005235-22 (18 January 2012).</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1186/1745-6215-15-501) contains supplementary material, which is available to authorized users.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>Traumatic brain injury</kwd><kwd>Erythropoietin</kwd><kwd>Outcome</kwd><kwd>Critical care</kwd><kwd>Randomised controlled trials</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© The Author(s) 2014</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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