AustralieFrV1, Main, Exploration, bibRecord, 002E41

Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial

Identifieur interne : 002E41 ( Main/Exploration ); précédent : 002E40; suivant : 002E42

Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial

Auteurs : Alistair Nichol [Australie, Irlande (pays)] ; Craig French [Australie] ; Lorraine Little [Australie] ; Jeffrey Presneill [Australie] ; D James Cooper [Australie] ; Samir Haddad [Australie] ; Jacques Duranteau [Australie, France] ; Olivier Huet [France] ; Markus Skrifvars [Finlande] ; Yaseen Arabi [Australie] ; Rinaldo Bellomo [Australie]

Source :

Trials [ 1745-6215 ] ; 2015.

RBID : PMC:4326467

Descripteurs français

KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Humains, Interprétation statistique de données, Lésions encéphaliques (traitement médicamenteux), Protocoles cliniques, Sujet âgé, Taille d'échantillon, Thromboembolie (), Échographie-doppler, Érythropoïétine (usage thérapeutique), Évaluation de résultat (soins).
MESH :
- traitement médicamenteux : Lésions encéphaliques.
- usage thérapeutique : Érythropoïétine.
- Adolescent, Adulte, Adulte d'âge moyen, Humains, Interprétation statistique de données, Protocoles cliniques, Sujet âgé, Taille d'échantillon, Thromboembolie, Échographie-doppler, Évaluation de résultat (soins).

English descriptors

KwdEn :
- Adolescent, Adult, Aged, Brain Injuries (drug therapy), Clinical Protocols, Data Interpretation, Statistical, Erythropoietin (therapeutic use), Humans, Middle Aged, Outcome Assessment (Health Care), Sample Size, Thromboembolism (prevention & control), Ultrasonography, Doppler.
MESH :
- chemical , therapeutic use : Erythropoietin.
- drug therapy : Brain Injuries.
- prevention & control : Thromboembolism.
- Adolescent, Adult, Aged, Clinical Protocols, Data Interpretation, Statistical, Humans, Middle Aged, Outcome Assessment (Health Care), Sample Size, Ultrasonography, Doppler.

Abstract

Background

Traumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis.

Methods/design

The erythropoietin in traumatic brain injury trial is a stratified prospective, multi-centre, randomised, blinded, parallel-group, placebo-controlled phase III trial. It aims to determine whether the administration of erythropoietin compared to placebo improves neurological outcome in patients with moderate or severe traumatic brain injury at six months after injury. The trial is designed to recruit 606 patients between 15 and 65 years of age with severe (Glasgow Coma Score: 3 to 8) or moderate (Glasgow Coma Score: 9 to 12) traumatic brain injury in Australia, New Zealand, Kingdom of Saudi Arabia, France, Finland, Germany and Ireland.

Trial patients will receive either subcutaneous erythropoietin or placebo within 24 hours of injury, and weekly thereafter for up to three doses during the intensive care unit admission. The primary outcome will be the combined proportion of unfavourable neurological outcomes at six months: severe disability or death. Secondary outcomes will include the rate of proximal deep venous thrombosis detected by compression Doppler ultrasound, six-month mortality, the proportion of patients with composite vascular events (deep venous thrombosis, pulmonary embolism, myocardial infarction, cardiac arrest and cerebrovascular events) at six months and quality of life with health economic evaluations.

Discussion

When completed, the trial aims to provide evidence on the efficacy and safety of erythropoietin in traumatic brain injury patients, and to provide clear guidance for clinicians in their management of this devastating condition.

Trial registration

Australian New Zealand Clinical Trials registry: ACTRN12609000827235 (registered on 22 September 2009).

Clinicaltrials.gov: NCT00987454 (registered on 29 September 2009). European Drug Regulatory Authorities Clinical Trials: 2011-005235-22 (registered on 18 January 2012).

Electronic supplementary material

The online version of this article (doi:10.1186/s13063-014-0528-6) contains supplementary material, which is available to authorized users.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4326467

DOI: 10.1186/s13063-014-0528-6
PubMed: 25884605
PubMed Central: 4326467

Affiliations:

Le document en format XML

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<author><name sortKey="Duranteau, Jacques" sort="Duranteau, Jacques" uniqKey="Duranteau J" first="Jacques" last="Duranteau">Jacques Duranteau</name>
<affiliation wicri:level="3"><nlm:aff id="Aff1">Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
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<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
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<affiliation wicri:level="3"><nlm:aff id="Aff9">Service d’Anesthésie-Réanimation, Hôpitaux universitaires Paris Sud, Assistance Publique des Hôpitaux de Paris, Hôpital de Bicêtre, 78, rue du Général Leclerc, 94275 Le Kremlin Bicêtre, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Service d’Anesthésie-Réanimation, Hôpitaux universitaires Paris Sud, Assistance Publique des Hôpitaux de Paris, Hôpital de Bicêtre, 78, rue du Général Leclerc, 94275 Le Kremlin Bicêtre</wicri:regionArea>
<placeName><region type="region" nuts="2">Île-de-France</region>
<settlement type="city">Le Kremlin Bicêtre</settlement>
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<author><name sortKey="Huet, Olivier" sort="Huet, Olivier" uniqKey="Huet O" first="Olivier" last="Huet">Olivier Huet</name>
<affiliation wicri:level="3"><nlm:aff id="Aff10">Department of Anesthesiology and Intensive Care Medicine, Centre Hospitalier Universitaire La Cavale Blanche Université de Bretagne Ouest, 29609 Brest Cedex, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Anesthesiology and Intensive Care Medicine, Centre Hospitalier Universitaire La Cavale Blanche Université de Bretagne Ouest, 29609 Brest Cedex</wicri:regionArea>
<placeName><region type="region" nuts="2">Région Bretagne</region>
<settlement type="city">Brest</settlement>
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<author><name sortKey="Skrifvars, Markus" sort="Skrifvars, Markus" uniqKey="Skrifvars M" first="Markus" last="Skrifvars">Markus Skrifvars</name>
<affiliation wicri:level="1"><nlm:aff id="Aff11">Department of Anaesthesiology and Intensive Care Medicine, Helsinki University Hospital, PO Box 266, FIN-00029 Helsinki, Finland</nlm:aff>
<country xml:lang="fr">Finlande</country>
<wicri:regionArea>Department of Anaesthesiology and Intensive Care Medicine, Helsinki University Hospital, PO Box 266, FIN-00029 Helsinki</wicri:regionArea>
<wicri:noRegion>FIN-00029 Helsinki</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="3"><nlm:aff id="Aff1">Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, 99 Commercial Road, Melbourne</wicri:regionArea>
<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
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<affiliation><nlm:aff id="Aff12">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>
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<author><name sortKey="Bellomo, Rinaldo" sort="Bellomo, Rinaldo" uniqKey="Bellomo R" first="Rinaldo" last="Bellomo">Rinaldo Bellomo</name>
<affiliation wicri:level="3"><nlm:aff id="Aff1">Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, 3004 Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, 99 Commercial Road, Melbourne</wicri:regionArea>
<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
</affiliation>
<affiliation wicri:level="4"><nlm:aff id="Aff6">Department of Medicine North West Academic Centre, The University of Melbourne, Grattan Street, Parkville, 3052 Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Department of Medicine North West Academic Centre, The University of Melbourne, Grattan Street, Parkville</wicri:regionArea>
<orgName type="university">Université de Melbourne</orgName>
<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
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<affiliation wicri:level="1"><nlm:aff id="Aff13">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>
<wicri:noRegion>Heidelberg</wicri:noRegion>
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<series><title level="j">Trials</title>
<idno type="eISSN">1745-6215</idno>
<imprint><date when="2015">2015</date>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Brain Injuries (drug therapy)</term>
<term>Clinical Protocols</term>
<term>Data Interpretation, Statistical</term>
<term>Erythropoietin (therapeutic use)</term>
<term>Humans</term>
<term>Middle Aged</term>
<term>Outcome Assessment (Health Care)</term>
<term>Sample Size</term>
<term>Thromboembolism (prevention & control)</term>
<term>Ultrasonography, Doppler</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Humains</term>
<term>Interprétation statistique de données</term>
<term>Lésions encéphaliques (traitement médicamenteux)</term>
<term>Protocoles cliniques</term>
<term>Sujet âgé</term>
<term>Taille d'échantillon</term>
<term>Thromboembolie ()</term>
<term>Échographie-doppler</term>
<term>Érythropoïétine (usage thérapeutique)</term>
<term>Évaluation de résultat (soins)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Erythropoietin</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Brain Injuries</term>
</keywords>
<keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Thromboembolism</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Lésions encéphaliques</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Érythropoïétine</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Clinical Protocols</term>
<term>Data Interpretation, Statistical</term>
<term>Humans</term>
<term>Middle Aged</term>
<term>Outcome Assessment (Health Care)</term>
<term>Sample Size</term>
<term>Ultrasonography, Doppler</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Humains</term>
<term>Interprétation statistique de données</term>
<term>Protocoles cliniques</term>
<term>Sujet âgé</term>
<term>Taille d'échantillon</term>
<term>Thromboembolie</term>
<term>Échographie-doppler</term>
<term>Évaluation de résultat (soins)</term>
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>Traumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis.</p>
</sec>
<sec><title>Methods/design</title>
<p>The erythropoietin in traumatic brain injury trial is a stratified prospective, multi-centre, randomised, blinded, parallel-group, placebo-controlled phase III trial. It aims to determine whether the administration of erythropoietin compared to placebo improves neurological outcome in patients with moderate or severe traumatic brain injury at six months after injury. The trial is designed to recruit 606 patients between 15 and 65 years of age with severe (Glasgow Coma Score: 3 to 8) or moderate (Glasgow Coma Score: 9 to 12) traumatic brain injury in Australia, New Zealand, Kingdom of Saudi Arabia, France, Finland, Germany and Ireland.</p>
<p>Trial patients will receive either subcutaneous erythropoietin or placebo within 24 hours of injury, and weekly thereafter for up to three doses during the intensive care unit admission. The primary outcome will be the combined proportion of unfavourable neurological outcomes at six months: severe disability or death. Secondary outcomes will include the rate of proximal deep venous thrombosis detected by compression Doppler ultrasound, six-month mortality, the proportion of patients with composite vascular events (deep venous thrombosis, pulmonary embolism, myocardial infarction, cardiac arrest and cerebrovascular events) at six months and quality of life with health economic evaluations.</p>
</sec>
<sec><title>Discussion</title>
<p>When completed, the trial aims to provide evidence on the efficacy and safety of erythropoietin in traumatic brain injury patients, and to provide clear guidance for clinicians in their management of this devastating condition.</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/TrialSearch.aspx?searchTxt=12609000827235&ddlSearch=Registered">ACTRN12609000827235</ext-link>
 (registered on 22 September 2009).</p>
<p>Clinicaltrials.gov: <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT00987454">NCT00987454</ext-link>
 (registered on 29 September 2009). European Drug Regulatory Authorities Clinical Trials: 2011-005235-22 (registered on 18 January 2012).</p>
</sec>
<sec><title>Electronic supplementary material</title>
<p>The online version of this article (doi:10.1186/s13063-014-0528-6) contains supplementary material, which is available to authorized users.</p>
</sec>
</div>
</front>
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<author><name sortKey="Murray, Gd" uniqKey="Murray G">GD Murray</name>
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<author><name sortKey="Miller, Mm" uniqKey="Miller M">MM Miller</name>
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<author><name sortKey="Kleinman, Lc" uniqKey="Kleinman L">LC Kleinman</name>
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<li>Finlande</li>
<li>France</li>
<li>Irlande (pays)</li>
</country>
<region><li>Région Bretagne</li>
<li>Victoria (État)</li>
<li>Île-de-France</li>
</region>
<settlement><li>Brest</li>
<li>Le Kremlin Bicêtre</li>
<li>Melbourne</li>
</settlement>
<orgName><li>Université de Melbourne</li>
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<tree><country name="Australie"><region name="Victoria (État)"><name sortKey="Nichol, Alistair" sort="Nichol, Alistair" uniqKey="Nichol A" first="Alistair" last="Nichol">Alistair Nichol</name>
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<name sortKey="Bellomo, Rinaldo" sort="Bellomo, Rinaldo" uniqKey="Bellomo R" first="Rinaldo" last="Bellomo">Rinaldo Bellomo</name>
<name sortKey="Cooper, D James" sort="Cooper, D James" uniqKey="Cooper D" first="D James" last="Cooper">D James Cooper</name>
<name sortKey="Cooper, D James" sort="Cooper, D James" uniqKey="Cooper D" first="D James" last="Cooper">D James Cooper</name>
<name sortKey="Duranteau, Jacques" sort="Duranteau, Jacques" uniqKey="Duranteau J" first="Jacques" last="Duranteau">Jacques Duranteau</name>
<name sortKey="French, Craig" sort="French, Craig" uniqKey="French C" first="Craig" last="French">Craig French</name>
<name sortKey="French, Craig" sort="French, Craig" uniqKey="French C" first="Craig" last="French">Craig French</name>
<name sortKey="Haddad, Samir" sort="Haddad, Samir" uniqKey="Haddad S" first="Samir" last="Haddad">Samir Haddad</name>
<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>
<name sortKey="Presneill, Jeffrey" sort="Presneill, Jeffrey" uniqKey="Presneill J" first="Jeffrey" last="Presneill">Jeffrey Presneill</name>
<name sortKey="Presneill, Jeffrey" sort="Presneill, Jeffrey" uniqKey="Presneill J" first="Jeffrey" last="Presneill">Jeffrey Presneill</name>
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<country name="Irlande (pays)"><noRegion><name sortKey="Nichol, Alistair" sort="Nichol, Alistair" uniqKey="Nichol A" first="Alistair" last="Nichol">Alistair Nichol</name>
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<name sortKey="Nichol, Alistair" sort="Nichol, Alistair" uniqKey="Nichol A" first="Alistair" last="Nichol">Alistair Nichol</name>
</country>
<country name="France"><region name="Île-de-France"><name sortKey="Duranteau, Jacques" sort="Duranteau, Jacques" uniqKey="Duranteau J" first="Jacques" last="Duranteau">Jacques Duranteau</name>
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<name sortKey="Huet, Olivier" sort="Huet, Olivier" uniqKey="Huet O" first="Olivier" last="Huet">Olivier Huet</name>
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<country name="Finlande"><noRegion><name sortKey="Skrifvars, Markus" sort="Skrifvars, Markus" uniqKey="Skrifvars M" first="Markus" last="Skrifvars">Markus Skrifvars</name>
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</country>
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</affiliations>
</record>

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Serveur d'exploration sur les relations entre la France et l'Australie

Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial

Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial

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	Serveur d'exploration sur les relations entre la France et l'Australie
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