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Penumbral Rescue by Normobaric O=O Administration in Patients With Ischaemic Stroke and Target Mismatch ProFile: A Phase II Proof-of-Concept Trial

Objective

Ischemic stroke (IS), caused by occlusion of arteries that supply blood to the brain, remains a leading cause of mortality and morbidity in the world. Disruption of blood and oxygen supply to the brain leads to neuronal death in the ischemic core within minutes. The hypoperfused tissue surrounding the ischemic core, the penumbra, is at high risk for infarction over time but still salvageable. Neuroprotective “bridging”, sustaining the penumbra until reperfusion, may widen the therapeutic window, make recanalization treatments accessible to more patients and improve overall IS outcomes.
As ischemic cell death is primarily mediated by hypoxia, increasing oxygen supply to the penumbra seems THE logical approach. In animal models of IS, normobaric hyperoxygenation (NBHO) significantly increased penumbral oxygen pressure and attenuated brain injury when initiated early after onset of ischaemia and vessel occlusion was transient (35 to 50% infarct volume reduction).
The PROOF project now seeks to demonstrate that NBHO (high-flow 100% oxygen at >45 L/min via a non-rebreather mask, or FiO2=1.0 for intubation/ventilation) reduces infarct growth from baseline to 24 hours compared to standard treatment if administered ≤3 hours after onset of anterior circulation IS, in patients with proximal vessel occlusion and salvageable tissue at risk. The study is multi-center, adaptive phase-IIb, randomized, open-label with blinded-endpoint (PROBE design).
The primary efficacy criterion will be infarct growth from baseline to 24 hours. Secondary endpoints will be NIHSS 24h, categorical shift in the pre-stroke modified Rankin Score, QoL and cognition at day 90.
Potential surrogate biomarkers, health economics and societal impacts will be assessed.
If NBHO proves its neuroprotective potential in this selected population, phase-III trials in all IS patients may be undertaken. Considering its low costs and ease of use, NBHO may impact stroke care worldwide.

Call for proposal

H2020-SC1-2016-2017

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Sub call

H2020-SC1-2016-RTD

Coordinator

EBERHARD KARLS UNIVERSITAET TUEBINGEN
Net EU contribution
€ 1 442 192,74
Address
Geschwister-scholl-platz
72074 Tuebingen
Germany

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Region
Baden-Württemberg Tübingen Tübingen, Landkreis
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00

Participants (15)

Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

Universitaetsklinikum Tuebingen
Germany
Net EU contribution
€ 56 550,00
Address
Geissweg 3
72076 Tuebingen

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Region
Baden-Württemberg Tübingen Tübingen, Landkreis
Activity type
Research Organisations
Non-EU contribution
€ 0,00
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
Net EU contribution
€ 321 625,00
Address
Oude Markt 13
3000 Leuven

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Region
Vlaams Gewest Prov. Vlaams-Brabant Arr. Leuven
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
FAKULTNI NEMOCNICE U SV. ANNY V BRNE
Czechia
Net EU contribution
€ 118 650,00
Address
Pekarska 53
656 91 Brno

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Region
Jihovýchod Jihomoravský kraj
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ
Finland
Net EU contribution
€ 137 463,00
Address
Stenbackinkatu 9
00029 Helsinki

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Region
Manner-Suomi Helsinki-Uusimaa Helsinki-Uusimaa
Activity type
Research Organisations
Non-EU contribution
€ 0,00
GROUPE HOSPITALIER UNIVERSITAIRE PARIS PSYCHIATRIE ET NEUROSCIENCES
France
Net EU contribution
€ 246 814,00
Address
Rue Cabanis 1
75014 Paris

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Ile-de-France Ile-de-France Paris
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Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA
Spain
Net EU contribution
€ 715 274,50
Address
Passeig Vall D Hebron 119-129 Edificio De Recerca
08035 Barcelona

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Region
Este Cataluña Barcelona
Activity type
Research Organisations
Non-EU contribution
€ 0,00
VÄSTRA GÖTALANDSREGIONEN
Sweden
Net EU contribution
€ 185 600,00
Address
Regionens Hus
462 80 Vanersborg

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Region
Södra Sverige Västsverige Västra Götalands län
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Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS
Switzerland
Net EU contribution
€ 26 225,00
Address
Rue Du Bugnon 21
1011 Lausanne

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Region
Schweiz/Suisse/Svizzera Région lémanique Vaud
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Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
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€ 0,00
EPPDATA GMBH
Germany
Net EU contribution
€ 737 875,00
Address
Mehlbeerweg 10
22391 Hamburg

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Hamburg Hamburg Hamburg
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
STROKE ALLIANCE FOR EUROPE
Belgium
Net EU contribution
€ 66 625,00
Address
Rue Washington 40
1050 Brussels

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Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Other
Non-EU contribution
€ 0,00
UNIVERSITATSKLINIKUM HEIDELBERG
Germany
Net EU contribution
€ 1 350 776,25
Address
Im Neuenheimer Feld 672
69120 Heidelberg

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Region
Baden-Württemberg Karlsruhe Heidelberg, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
Net EU contribution
€ 219 422,69
Address
5 Rue Watt
75013 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

LUXEMBOURG INSTITUTE OF HEALTH
Luxembourg
Net EU contribution
€ 121 424,00
Address
Val Fleuri 84
1526 Luxembourg

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Region
Luxembourg Luxembourg Luxembourg
Activity type
Research Organisations
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

Masarykova univerzita
Czechia
Net EU contribution
€ 13 465,00
Address
Zerotinovo Namesti 9
601 77 Brno

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Jihovýchod Jihomoravský kraj
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

KKS-NETZWERK EV -NETZWERK DER KOORDINIERUNGSZENTREN FUR KLINISCHE STUDIEN
Germany
Net EU contribution
€ 18 845,31
Address
Alt-moabit 96 A
10559 Berlin

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Region
Berlin Berlin Berlin
Activity type
Research Organisations
Non-EU contribution
€ 0,00