Cause and timing of death and sub-group differential effects of erythropoietin in the EPO-TBI study.
Identifieur interne : 005015 ( Ncbi/Checkpoint ); précédent : 005014; suivant : 005016Cause and timing of death and sub-group differential effects of erythropoietin in the EPO-TBI study.
Auteurs : Markus Benedict Skrifvars [Finlande] ; Craig French [Australie] ; Michael Bailey [États-Unis] ; Jeffrey Presneill [Australie] ; Alistair Nichol [États-Unis] ; Lorraine Little [États-Unis] ; Jacques Duranteau [France] ; Olivier Huet [France] ; Samir Haddad [Oman] ; Yaseen Arabi [Oman] ; Colin Mcarthur [Nouvelle-Zélande] ; D James Cooper ; Rinaldo Bellomo [Australie]Source :
- Journal of neurotrauma [ 1557-9042 ] ; 2017.
Abstract
The EPO-TBI study randomised 606 patients with moderate or severe traumatic brain injury (TBI) to be treated with weekly epoetin alfa (EPO) or placebo. Six-month mortality was lower in EPO treated patients in an analysis adjusting for TBI severity. Knowledge of possible differential effects by TBI injury subtype and acute neurosurgical treatment as well as timing and cause of death (COD) will facilitate the design of future interventional TBI trials. We defined COD as cerebral (brain death, cerebral death with withdrawal or death during maximal care) and non-cerebral (death following withdrawal or during maximal care due to a non-cerebral cause). The study included 305 patients treated with EPO and 297 with placebo, with COD recorded in 77 (99%) out of 78 non-survivors. Median time to death in patients dying of cerebral COD was 8 days (IQR 5-16) compared to 29 days (IQR 7-56) (p=0.01) with non-cerebral COD. When assessing subgroups by admission computed tomography scan injury findings, we found no significant differential effects of EPO compared to placebo. However, EPO appeared more effective in patients with an injury type not requiring a neurosurgical operation prior to ICU admission (OR 0.29, 95% confidence interval 0.14-0.61, p=0.001, p for interaction = 0.003) and in this sub-group, fewer patients died of cerebral causes in in the EPO compared to placebo group (5% compared to 14%, p=0.03). In conclusion, most TBI deaths were due to cerebral causesthat occurred during the first two weeks, and were related to withdrawal of care. EPO appeared to specifically reduce cerebral deaths in the important subgroup of patients with a diffuse type of injury not requiring a neurosurgical intervention prior to randomisation.
DOI: 10.1089/neu.2017.5135
PubMed: 29020866
Affiliations:
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markus.skrifvars@hus.fi.</nlm:affiliation><country wicri:rule="url">Finlande</country><wicri:regionArea>Helsinki University Hospital, Department of Anesthesia, Intensive Care and Pain Medicine , Haartmaninkatu 9 , 00029 HUS , HUS, Finland </wicri:regionArea><wicri:noRegion>Finland </wicri:noRegion></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:affiliation>Department of Intensive Care, Western Health, Melbourne, Victoria, Australia, Melbourne, Victoria, Australia ; Craig.French@wh.org.au.</nlm:affiliation><country wicri:rule="url">Australie</country><wicri:regionArea>Department of Intensive Care, Western Health, Melbourne, Victoria, Australia, Melbourne, Victoria</wicri:regionArea><wicri:noRegion>Victoria</wicri:noRegion></affiliation></author><author><name sortKey="Bailey, Michael" sort="Bailey, Michael" uniqKey="Bailey M" first="Michael" last="Bailey">Michael Bailey</name><affiliation wicri:level="1"><nlm:affiliation>Monash University, School of Public Health and Preventive Medicine, Melbourne, Victoria, Australia ; Michael.Bailey@monash.edu.</nlm:affiliation><country wicri:rule="url">États-Unis</country><wicri:regionArea>Monash University, School of Public Health and Preventive Medicine, Melbourne, Victoria</wicri:regionArea><wicri:noRegion>Victoria</wicri:noRegion></affiliation></author><author><name sortKey="Presneill, Jeffrey" sort="Presneill, Jeffrey" uniqKey="Presneill J" first="Jeffrey" last="Presneill">Jeffrey Presneill</name><affiliation wicri:level="1"><nlm:affiliation>Royal Melbourne Hospital, 90134, Department of Intensive Care, Melbourne, Victoria, Australia ; intensive@fastmail.com.au.</nlm:affiliation><country wicri:rule="url">Australie</country><wicri:regionArea>Royal Melbourne Hospital, 90134, Department of Intensive Care, Melbourne, Victoria</wicri:regionArea><wicri:noRegion>Victoria</wicri:noRegion></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:affiliation>Monash University School of Public Health and Preventive Medicine, 161667, ANZIC-RC, Melbourne, Victoria, Australia ; Alistair.Nichol@monash.edu.</nlm:affiliation><country wicri:rule="url">États-Unis</country><wicri:regionArea>Monash University School of Public Health and Preventive Medicine, 161667, ANZIC-RC, Melbourne, Victoria</wicri:regionArea><wicri:noRegion>Victoria</wicri:noRegion></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:affiliation>Monash University School of Public Health and Preventive Medicine, 161667, ANZIC-RC, Melbourne, Victoria, Australia ; lorraine.little@monash.edu.</nlm:affiliation><country wicri:rule="url">États-Unis</country><wicri:regionArea>Monash University School of Public Health and Preventive Medicine, 161667, ANZIC-RC, Melbourne, Victoria</wicri:regionArea><wicri:noRegion>Victoria</wicri:noRegion></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:affiliation>Hopitaux Universitaires Paris-Sud, 378965, Department of Anesthesia and Intensive Care, Le Kremlin-Bicetre, Île-de-France, France ; jacques.duranteau@aphp.fr.</nlm:affiliation><country wicri:rule="url">France</country><wicri:regionArea>Hopitaux Universitaires Paris-Sud, 378965, Department of Anesthesia and Intensive Care, Le Kremlin-Bicetre, Île-de-France</wicri:regionArea><wicri:noRegion>Île-de-France</wicri:noRegion><wicri:noRegion>Île-de-France</wicri:noRegion></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:affiliation>Hopital de la Cavale-Blanche, 55359, Departement d'anesthésie-réanimation, Brest, Bretagne, France ; olivier.huet@chu-brest.fr.</nlm:affiliation><country wicri:rule="url">France</country><wicri:regionArea>Hopital de la Cavale-Blanche, 55359, Departement d'anesthésie-réanimation, Brest, Bretagne</wicri:regionArea><wicri:noRegion>Bretagne</wicri:noRegion><wicri:noRegion>Bretagne</wicri:noRegion></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:affiliation>King Abdullah International Medical Research Center, 309817, Intensive Care Department, Riyadh, Saudi Arabia ; samir.haddads55@yahoo.com.</nlm:affiliation><country wicri:rule="url">Oman</country><wicri:regionArea>King Abdullah International Medical Research Center, 309817, Intensive Care Department, Riyadh</wicri:regionArea><wicri:noRegion>Riyadh</wicri:noRegion></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:affiliation>King Saud bin Abdulaziz University for Health Sciences, 48149, Intensive Care Department, Riyadh, Saudi Arabia ; yaseenarabi@yahoo.com.</nlm:affiliation><country wicri:rule="url">Oman</country><wicri:regionArea>King Saud bin Abdulaziz University for Health Sciences, 48149, Intensive Care Department, Riyadh</wicri:regionArea><wicri:noRegion>Riyadh</wicri:noRegion></affiliation></author><author><name sortKey="Mcarthur, Colin" sort="Mcarthur, Colin" uniqKey="Mcarthur C" first="Colin" last="Mcarthur">Colin Mcarthur</name><affiliation wicri:level="1"><nlm:affiliation>Auckland City Hospital, 58991, Department of Critical Care Medicine, Auckland, New Zealand ; colinm@adhb.govt.nz.</nlm:affiliation><country wicri:rule="url">Nouvelle-Zélande</country><wicri:regionArea>Auckland City Hospital, 58991, Department of Critical Care Medicine, Auckland</wicri:regionArea><wicri:noRegion>Auckland</wicri:noRegion></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><nlm:affiliation>The Alfred, Intensive Care , Commercial Road , Melbourne, Victoria, Australia , 3004.</nlm:affiliation><wicri:noCountry code="subField">3004</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:affiliation>Monash University, ANZIC-RC , Level 6 , The Alfred Centre , 99 Commercial Road , Melbourne, Victoria, Australia , 3004 ; rinaldo.bellomo@austin.org.au.</nlm:affiliation><country wicri:rule="url">Australie</country><wicri:regionArea>Monash University, ANZIC-RC , Level 6 , The Alfred Centre , 99 Commercial Road , Melbourne, Victoria, Australia </wicri:regionArea><wicri:noRegion>Australia </wicri:noRegion></affiliation></author></analytic><series><title level="j">Journal of neurotrauma</title><idno type="eISSN">1557-9042</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The EPO-TBI study randomised 606 patients with moderate or severe traumatic brain injury (TBI) to be treated with weekly epoetin alfa (EPO) or placebo. Six-month mortality was lower in EPO treated patients in an analysis adjusting for TBI severity. Knowledge of possible differential effects by TBI injury subtype and acute neurosurgical treatment as well as timing and cause of death (COD) will facilitate the design of future interventional TBI trials. We defined COD as cerebral (brain death, cerebral death with withdrawal or death during maximal care) and non-cerebral (death following withdrawal or during maximal care due to a non-cerebral cause). The study included 305 patients treated with EPO and 297 with placebo, with COD recorded in 77 (99%) out of 78 non-survivors. Median time to death in patients dying of cerebral COD was 8 days (IQR 5-16) compared to 29 days (IQR 7-56) (p=0.01) with non-cerebral COD. When assessing subgroups by admission computed tomography scan injury findings, we found no significant differential effects of EPO compared to placebo. However, EPO appeared more effective in patients with an injury type not requiring a neurosurgical operation prior to ICU admission (OR 0.29, 95% confidence interval 0.14-0.61, p=0.001, p for interaction = 0.003) and in this sub-group, fewer patients died of cerebral causes in in the EPO compared to placebo group (5% compared to 14%, p=0.03). In conclusion, most TBI deaths were due to cerebral causesthat occurred during the first two weeks, and were related to withdrawal of care. EPO appeared to specifically reduce cerebral deaths in the important subgroup of patients with a diffuse type of injury not requiring a neurosurgical intervention prior to randomisation.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Finlande</li><li>France</li><li>Nouvelle-Zélande</li><li>Oman</li><li>États-Unis</li></country></list><tree><noCountry><name sortKey="Cooper, D James" sort="Cooper, D James" uniqKey="Cooper D" first="D James" last="Cooper">D James Cooper</name></noCountry><country name="Finlande"><noRegion><name sortKey="Skrifvars, Markus Benedict" sort="Skrifvars, Markus Benedict" uniqKey="Skrifvars M" first="Markus Benedict" last="Skrifvars">Markus Benedict Skrifvars</name></noRegion></country><country name="Australie"><noRegion><name sortKey="French, Craig" sort="French, Craig" uniqKey="French C" first="Craig" last="French">Craig French</name></noRegion><name sortKey="Bellomo, Rinaldo" sort="Bellomo, Rinaldo" uniqKey="Bellomo R" first="Rinaldo" last="Bellomo">Rinaldo Bellomo</name><name sortKey="Presneill, Jeffrey" sort="Presneill, Jeffrey" uniqKey="Presneill J" first="Jeffrey" last="Presneill">Jeffrey Presneill</name></country><country name="États-Unis"><noRegion><name sortKey="Bailey, Michael" sort="Bailey, Michael" uniqKey="Bailey M" first="Michael" last="Bailey">Michael Bailey</name></noRegion><name sortKey="Little, Lorraine" sort="Little, Lorraine" uniqKey="Little L" first="Lorraine" last="Little">Lorraine Little</name><name sortKey="Nichol, Alistair" sort="Nichol, Alistair" uniqKey="Nichol A" first="Alistair" last="Nichol">Alistair Nichol</name></country><country name="France"><noRegion><name sortKey="Duranteau, Jacques" sort="Duranteau, Jacques" uniqKey="Duranteau J" first="Jacques" last="Duranteau">Jacques Duranteau</name></noRegion><name sortKey="Huet, Olivier" sort="Huet, Olivier" uniqKey="Huet O" first="Olivier" last="Huet">Olivier Huet</name></country><country name="Oman"><noRegion><name sortKey="Haddad, Samir" sort="Haddad, Samir" uniqKey="Haddad S" first="Samir" last="Haddad">Samir Haddad</name></noRegion><name sortKey="Arabi, Yaseen" sort="Arabi, Yaseen" uniqKey="Arabi Y" first="Yaseen" last="Arabi">Yaseen Arabi</name></country><country name="Nouvelle-Zélande"><noRegion><name sortKey="Mcarthur, Colin" sort="Mcarthur, Colin" uniqKey="Mcarthur C" first="Colin" last="Mcarthur">Colin Mcarthur</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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