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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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Outcomes and
results

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.

cell risk 45 seems recanalization volume time endpoints impacts administered flow acirc proximal probe hypoxia rankin qol infarct hours intubation primary baseline initiated population animal morbidity injury secondary mortality economics 100 oxygen nihss patients surrogate oelig proof occlusion stroke iib societal disruption min leads rebreather brain 24h primarily vessel criterion endpoint minutes mask attenuated blinded cognition widen undertaken until ischaemia 50 ease caused nbho anterior sustaining significantly 1 therapeutic onset outcomes surrounding modified logical reperfusion infarction care mediated permil death categorical score penumbral adaptive accessible 35 hypoperfused models world efficacy label core supply neuronal treatments ventilation 24 pressure salvageable reduces curren circulation considering penumbra window center neuroprotective bridging fio2 trials shift arteries tissue gt day health blood hyperoxygenation transient treatment worldwide proves ischemic biomarkers normobaric standard randomized

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 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.	DE (TUEBINGEN)	coordinator	1˙498˙742.00
2	UNIVERSITATSKLINIKUM HEIDELBERG UNIVERSITATSKLINIKUM HEIDELBERG Organization address address: IM NEUENHEIMER FELD 672 city: HEIDELBERG postcode: 69120 website: www.klinikum.uni-heidelberg.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (HEIDELBERG)	participant	1˙350˙776.00
3	EPPDATA GMBH EPPDATA GMBH Organization address address: MEHLBEERWEG 10 city: HAMBURG postcode: 22391 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (HAMBURG)	participant	737˙875.00
4	FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA Organization address address: PASSEIG VALL D HEBRON 119-129 EDIFICIO DE RECERCA city: BARCELONA postcode: 8035 website: http://www.vhir.org/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (BARCELONA)	participant	679˙923.00
5	ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK Organization address address: 5 RUE WATT city: PARIS postcode: 75013 website: www.ecrin.org contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	434˙733.00
6	KATHOLIEKE UNIVERSITEIT LEUVEN KATHOLIEKE UNIVERSITEIT LEUVEN Organization address address: OUDE MARKT 13 city: LEUVEN postcode: 3000 website: www.kuleuven.be contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (LEUVEN)	participant	321˙625.00
7	CENTRE HOSPITALIER SAINTE ANNE DE PARIS CENTRE HOSPITALIER SAINTE ANNE DE PARIS Organization address address: RUE CABANIS 1 city: PARIS CEDEX 14 postcode: 75674 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS CEDEX 14)	participant	246˙814.00
8	VASTRA GOTALANDS LANS LANDSTING VASTRA GOTALANDS LANS LANDSTING Organization address address: REGIONENS HUS city: VANERSBORG postcode: 462 80 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	SE (VANERSBORG)	participant	185˙600.00
9	HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ Organization address address: STENBACKINKATU 9 city: HELSINKI postcode: 29 website: www.hus.fi contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FI (HELSINKI)	participant	137˙463.00
10	FAKULTNI NEMOCNICE U SV. ANNY V BRNE FAKULTNI NEMOCNICE U SV. ANNY V BRNE Organization address address: Pekarska 53 city: Brno postcode: 656 91 website: www.fnusa.cz contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CZ (Brno)	participant	118˙650.00
11	STROKE ALLIANCE FOR EUROPE STROKE ALLIANCE FOR EUROPE Organization address address: RUE WASHINGTON 40 city: BRUSSELS postcode: 1050 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (BRUSSELS)	participant	66˙625.00
12	CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS Organization address address: RUE DU BUGNON 21 city: LAUSANNE postcode: 1011 website: www.chuv.ch contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	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 â€œbridgingâ€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 â‰¤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

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