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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.

Field of science

  • /medical and health sciences/basic medicine/neurology/stroke

Call for proposal

H2020-PHC-2014-two-stage
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Address
Heidelberglaan 100
3584 CX Utrecht
Netherlands
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 592 763,25

Participants (18)

THE UNIVERSITY OF NOTTINGHAM
United Kingdom
EU contribution
€ 114 597,50
Address
University Park
NG7 2RD Nottingham
Activity type
Higher or Secondary Education Establishments
OSLO UNIVERSITETSSYKEHUS HF
Norway
EU contribution
€ 476 625
Address
Kirkeveien 166 Tarnbygget
0450 Oslo
Activity type
Higher or Secondary Education Establishments
AZIENDA SOCIO SANITARIA TERRITORIALE DI MANTOVA(ASST DI MANTOVA)
Italy
EU contribution
€ 250 360
Address
Strada Lago Paiolo 10
46100 Mantova
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
DEBRECENI EGYETEM
Hungary
EU contribution
€ 257 600
Address
Egyetem Ter 1
4032 Debrecen
Activity type
Higher or Secondary Education Establishments
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
EU contribution
€ 539 595
Address
5 Rue Watt
75013 Paris
Activity type
Research Organisations
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Netherlands
EU contribution
€ 23 065
Address
Dr Molewaterplein 40
3015 GD Rotterdam
Activity type
Higher or Secondary Education Establishments
INSTYTUT PSYCHIATRII I NEUROLOGII
Poland
EU contribution
€ 230 100
Address
Ulica Sobieskiego 9
02 957 Warszawa
Activity type
Research Organisations
SIHTASUTUS TARTU ULIKOOLI KLIINIKUM
Estonia
EU contribution
€ 121 725
Address
Puusepa 1A
50406 Tartu
Activity type
Research Organisations
UNIVERSITY OF GLASGOW
United Kingdom
EU contribution
€ 263 726,25
Address
University Avenue
G12 8QQ Glasgow
Activity type
Higher or Secondary Education Establishments
THE UNIVERSITY OF EDINBURGH
United Kingdom
EU contribution
€ 362 653
Address
Old College, South Bridge
EH8 9YL Edinburgh
Activity type
Higher or Secondary Education Establishments
UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF
Germany
EU contribution
€ 372 250
Address
Martinistrasse 52
20251 Hamburg
Activity type
Higher or Secondary Education Establishments
ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM
Netherlands
EU contribution
€ 323 165
Address
Meibergdreef 15
1105AZ Amsterdam
Activity type
Higher or Secondary Education Establishments
CTC NORTH GMBH & CO KG
Germany
EU contribution
€ 384 400
Address
Martinistrasse 64
20251 Hamburg
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
PANEPISTIMIO THESSALIAS
Greece
EU contribution
€ 236 350
Address
Argonafton Filellinon
38221 Volos
Activity type
Higher or Secondary Education Establishments
STROKE ALLIANCE FOR EUROPE
Belgium
EU contribution
€ 45 025
Address
Rue Washington 40
1050 Brussels
Activity type
Other
GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG

Participation ended

Germany
EU contribution
€ 82 016,20
Address
Oskar Von Miller Ring 29
80333 Muenchen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ARTTIC
France
EU contribution
€ 254 958
Address
Rue Du Dessous Des Berges 58A
75013 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ARTTIC INNOVATION GMBH
Germany
EU contribution
€ 63 025,80
Address
Oskar-von-miller-ring 29
80333 Munchen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)