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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.

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

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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