#	Pagina
attuale pagina	/open-h2020/projects/207449/index.html

Opendata, web and dolomites

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 €

0

EC-Contrib. €

0

Partnership

0

Views

0

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.

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 1 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 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

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

Are you the coordinator (or a participant) of this project? Plaese send me more information about the "PROOF" project.

For instance: the website url (it has not provided by EU-opendata yet), the logo, a more detailed description of the project (in plain text as a rtf file or a word file), some pictures (as picture files, not embedded into any word file), twitter account, linkedin page, etc.

Send me an email (fabio@fabiodisconzi.com) and I put them in your project's page as son as possible.

Thanks. And then put a link of this page into your project's website.

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

More projects from the same programme (H2020-EU.3.1.3.)

PanCareFollowUp (2019)

PanCareFollowUp: Novel, patient-centred survivorship care to improve care quality, effectiveness, cost-effectiveness and accessibility for survivors and caregivers

Read More

LEGACy (2019)

CeLac and European consortium for a personalized medicine approach to Gastric Cancer

Read More

GACD (2019)

Global Alliance for Chronic Diseases Secretariat

Read More