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PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke

Objective

Every year, 1.3 million Europeans have a stroke and one million ultimately die of stroke. One third of stroke patients remain dependent on the help of others. The annual costs for stroke care in Europe are estimated at € 64.1 billion. Stroke incidence increases almost exponentially with age, and the personal, societal, and economic burden of stroke is therefore largely driven by its frequent occurrence in the elderly. The elderly have been strongly underrepresented in previous stroke trials and treatment guidelines have no recommendations specific to this important group. Elderly patients are at the highest risk of complications after stroke, such as infections, fever, and dysphagia. These complications are strongly and independently associated with a higher risk of death or dependency.
We will perform a pragmatic, randomised, open clinical trial with blinded outcome assessment in at least 2500 patients with acute stroke aged 66 years or older, to assess whether pharmacological prevention of infections and fever, and early management of dysphagia, will reduce the risk of death, poor functional outcome, and poor quality of life, and lead to reductions in the costs of stroke care throughout Europe. Patients will be randomised using a factorial design to preventive treatment for 4 days with ceftriaxone, paracetamol, and/or metoclopramide, or to ‘standard care’ alone. The primary outcome is functional outcome at 3 months, assessed with the modified Rankin Scale (mRS), and analysed with ordinal logistic regression. The study will have 80% power to detect a statistically significant shift towards a favourable outcome, assuming a 5% absolute increase in the proportion of patients with a good outcome (mRS 0 to 2) in the intervention group, compared with controls. This simple, safe, and generally available treatment strategy has the potential to lead to an annual reduction of over 25 000 elderly Europeans being dead or dependent as a result of stroke, at very low costs.

Call for proposal

H2020-PHC-2014-2015

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Sub call

H2020-PHC-2014-two-stage

Coordinator

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Net EU contribution
€ 1 592 763,25
Address
Heidelberglaan 100
3584 CX Utrecht
Netherlands

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Region
West-Nederland Utrecht Utrecht
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,50

Participants (19)

THE UNIVERSITY OF NOTTINGHAM
United Kingdom
Net EU contribution
€ 114 597,50
Address
University Park
NG7 2RD Nottingham

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Region
East Midlands (England) Derbyshire and Nottinghamshire Nottingham
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
OSLO UNIVERSITETSSYKEHUS HF
Norway
Net EU contribution
€ 476 625,00
Address
Kirkeveien 166 Tarnbygget
0450 Oslo

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Region
Norge Oslo og Viken Oslo
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
AZIENDA SOCIO SANITARIA TERRITORIALE DI MANTOVA(ASST DI MANTOVA)
Italy
Net EU contribution
€ 250 360,00
Address
Strada Lago Paiolo 10
46100 Mantova

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Region
Nord-Ovest Lombardia Mantova
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
DEBRECENI EGYETEM
Hungary
Net EU contribution
€ 257 600,00
Address
Egyetem Ter 1
4032 Debrecen

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Region
Alföld és Észak Észak-Alföld Hajdú-Bihar
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
Net EU contribution
€ 539 595,00
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
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Netherlands
Net EU contribution
€ 23 065,00
Address
Dr Molewaterplein 40
3015 GD Rotterdam

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Region
West-Nederland Zuid-Holland Groot-Rijnmond
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
INSTYTUT PSYCHIATRII I NEUROLOGII
Poland
Net EU contribution
€ 230 100,00
Address
Ulica Sobieskiego 9
02 957 Warszawa

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Region
Makroregion województwo mazowieckie Warszawski stołeczny Miasto Warszawa
Activity type
Research Organisations
Non-EU contribution
€ 0,00
SIHTASUTUS TARTU ULIKOOLI KLIINIKUM
Estonia
Net EU contribution
€ 121 725,00
Address
Puusepa 1a
50406 Tartu

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Region
Eesti Eesti Lõuna-Eesti
Activity type
Research Organisations
Non-EU contribution
€ 0,00
UNIVERSITY OF GLASGOW
United Kingdom
Net EU contribution
€ 263 726,25
Address
University Avenue
G12 8QQ Glasgow

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Region
West Central Scotland Glasgow City
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
THE UNIVERSITY OF EDINBURGH
United Kingdom
Net EU contribution
€ 332 109,40
Address
Old College, South Bridge
EH8 9YL Edinburgh

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Region
Eastern Scotland Edinburgh
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.

LOTHIAN HEALTH BOARD
United Kingdom
Net EU contribution
€ 30 543,60
Address
Waterloo Place 2-4 Waverley Gate
EH1 3EG Edinburgh

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Region
Eastern Scotland Edinburgh
Activity type
Research Organisations
Non-EU contribution
€ 0,00
UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF
Germany
Net EU contribution
€ 372 250,00
Address
Martinistrasse 52
20251 Hamburg

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Region
Baden-Württemberg Stuttgart Stuttgart, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM
Netherlands
Net EU contribution
€ 323 165,00
Address
Meibergdreef 15
1105AZ Amsterdam

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Region
West-Nederland Noord-Holland Groot-Amsterdam
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
CTC NORTH GMBH & CO KG
Germany
Net EU contribution
€ 384 400,00
Address
Martinistrasse 64
20251 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
PANEPISTIMIO THESSALIAS
Greece
Net EU contribution
€ 236 350,00
Address
Argonafton Filellinon
38221 Volos

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Region
Μαγνησία Θεσσαλία Κεντρική Ελλάδα
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
STROKE ALLIANCE FOR EUROPE
Belgium
Net EU contribution
€ 45 025,00
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
GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG

Participation ended

Germany
Net EU contribution
€ 82 016,20
Address
Oskar Von Miller Ring 29
80333 Muenchen

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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
Bayern Oberbayern München, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
ARTTIC
France
Net EU contribution
€ 254 958,00
Address
39 Rue Des Mathurins
75008 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
ARTTIC INNOVATION GMBH
Germany
Net EU contribution
€ 63 025,80
Address
Oskar-von-miller-ring 29
80333 Munchen

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Region
Bayern Oberbayern München, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00