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PROOF SIGNED

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

Total Cost €

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EC-Contrib. €

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Partnership

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 PROOF project word cloud

Explore the words cloud of the PROOF project. It provides you a very rough idea of what is the project "PROOF" about.

significantly    neuronal    undertaken    care    bridging    sustaining    caused    attenuated    core    ischaemia    iib    minutes    impacts    treatment    pressure    categorical    trials    24h    death    volume    acirc    permil    hypoxia    randomized    day    neuroprotective    circulation    45    secondary    shift    surrogate    gt    animal    proof    recanalization    onset    disruption    cell    standard    salvageable    seems    tissue    outcomes    blinded    penumbral    qol    rankin    world    mortality    baseline    oelig    worldwide    supply    risk    reperfusion    primarily    100    health    initiated    arteries    label    penumbra    biomarkers    fio2    cognition    intubation    curren    accessible       flow    rebreather    administered    infarct    center    score    brain    blood    therapeutic    proves    transient    mediated    mask    35    morbidity    probe    population    24    ischemic    surrounding    models    treatments    patients    societal    normobaric    until    logical    proximal    hypoperfused    window    primary    occlusion    infarction    nbho    time    modified    nihss    ventilation    stroke    min    vessel    efficacy    widen    adaptive    oxygen    injury    50    hyperoxygenation    ease    economics    reduces    anterior    leads    considering    endpoints    criterion    endpoint    hours   

Project "PROOF" data sheet

The following table provides information about the project.

Coordinator
EBERHARD KARLS UNIVERSITAET TUEBINGEN 

Organization address
address: GESCHWISTER-SCHOLL-PLATZ
city: TUEBINGEN
postcode: 72074
website: www.uni-tuebingen.de

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Germany [DE]
 Project website http://www.proof-trial.eu
 Total cost 5˙997˙347 €
 EC max contribution 5˙778˙827 € (96%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-SC1-2016-RTD
 Funding Scheme RIA
 Starting year 2017
 Duration (year-month-day) from 2017-01-01   to  2021-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    EBERHARD KARLS UNIVERSITAET TUEBINGEN DE (TUEBINGEN) coordinator 1˙498˙742.00
2    UNIVERSITATSKLINIKUM HEIDELBERG DE (HEIDELBERG) participant 1˙350˙776.00
3    EPPDATA GMBH DE (HAMBURG) participant 737˙875.00
4    FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA ES (BARCELONA) participant 679˙923.00
5    ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK FR (PARIS) participant 434˙733.00
6    KATHOLIEKE UNIVERSITEIT LEUVEN BE (LEUVEN) participant 321˙625.00
7    CENTRE HOSPITALIER SAINTE ANNE DE PARIS FR (PARIS CEDEX 14) participant 246˙814.00
8    VASTRA GOTALANDS LANS LANDSTING SE (VANERSBORG) participant 185˙600.00
9    HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ FI (HELSINKI) participant 137˙463.00
10    FAKULTNI NEMOCNICE U SV. ANNY V BRNE CZ (Brno) participant 118˙650.00
11    STROKE ALLIANCE FOR EUROPE BE (BRUSSELS) participant 66˙625.00
12    CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS CH (LAUSANNE) participant 0.00

Map

 Project 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 “bridgingâ€Â, 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.

 Deliverables

List of deliverables.
PROOF communication and dissemination tools Documents, reports 2020-01-27 12:40:00
Final list of participating centres Documents, reports 2020-01-27 12:40:00
DSMB Formation Other 2020-01-27 12:40:00

Take a look to the deliverables list in detail:  detailed list of PROOF deliverables.

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The information about "PROOF" are provided by the European Opendata Portal: CORDIS opendata.

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