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

akronüüm: PRECIOUS
algus: 2015-06-01
lõpp: 2020-05-31
 
programm: H2020 - Horisont 2020
alaprogramm: HEALTH - Tervishoid, demograafilised muutused ja heaolu
instrument: RIA
projektikonkurss: H2020-PHC-2014-two-stage
projekti number: 634809
kestus kuudes: 60
partnerite arv: 17
 
lühikokkuvõte: 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 3800 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 90% 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.
partneri jrk nr ja roll partneri nimi riik kontaktisik koduleht
1 koordinaator UNIVERSITAIR MEDISCH CENTRUM UTRECHT NL H Bart VAN DER WORP http://www.umcutrecht.nl
2 partner THE UNIVERSITY OF NOTTINGHAM UK http://www.nottingham.ac.uk
3 partner OSLO UNIVERSITETSSYKEHUS HF NO http://www.oslo-universitetssykehus.no
4 partner AZIENDA OSPEDALIERA CARLO POMA IT http://www.asst-mantova.it
5 partner DEBRECENI EGYETEM HU http://www.unideb.hu
6 partner ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK FR http://www.ecrin.org
7 partner ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM NL http://www.erasmusmc.nl
8 partner INSTYTUT PSYCHIATRII I NEUROLOGII PL http://www.ipin.edu.pl
9 partner SIHTASUTUS TARTU ULIKOOLI KLIINIKUM EE http://www.kliinikum.ee
10 partner UNIVERSITY OF GLASGOW UK http://www.gla.ac.uk
11 partner THE UNIVERSITY OF EDINBURGH UK http://www.ed.ac.uk
12 partner UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF DE http://www.uke.uni-hamburg.de
13 partner Academisch Medisch Centrum bij de Universiteit van Amsterdam NL http://www.amc.nl
14 partner CTC NORTH GMBH & CO KG DE http://www.ctc-north.com
15 partner PANEPISTIMIO THESSALIAS EL
16 partner STROKE ALLIANCE FOR EUROPE BE
17 partner GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG DE http://www.gabo-mi.com