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

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 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.
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Coordinator

Utrecht University Medical Center

Address

Heidelberglaan 100
3584 Cx Utrecht

Netherlands

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 592 763,25

Participants (18)

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THE UNIVERSITY OF NOTTINGHAM

United Kingdom

EU Contribution

€ 114 597,50

OSLO UNIVERSITETSSYKEHUS HF

Norway

EU Contribution

€ 476 625

AZIENDA OSPEDALIERA CARLO POMA

Italy

AZIENDA SOCIO SANITARIA TERRITORIALE DI MANTOVA(ASST DI MANTOVA)

Italy

EU Contribution

€ 250 360

DEBRECENI EGYETEM

Hungary

EU Contribution

€ 257 600

ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK

France

EU Contribution

€ 539 595

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

Netherlands

EU Contribution

€ 23 065

INSTYTUT PSYCHIATRII I NEUROLOGII

Poland

EU Contribution

€ 230 100

SIHTASUTUS TARTU ULIKOOLI KLIINIKUM

Estonia

EU Contribution

€ 121 725

UNIVERSITY OF GLASGOW

United Kingdom

EU Contribution

€ 263 726,25

THE UNIVERSITY OF EDINBURGH

United Kingdom

EU Contribution

€ 362 653

UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF

Germany

EU Contribution

€ 372 250

Academisch Medisch Centrum bij de Universiteit van Amsterdam

Netherlands

EU Contribution

€ 323 165

CTC NORTH GMBH & CO KG

Germany

EU Contribution

€ 384 400

PANEPISTIMIO THESSALIAS

Greece

EU Contribution

€ 236 350

STROKE ALLIANCE FOR EUROPE

Belgium

EU Contribution

€ 45 025

GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG

Germany

EU Contribution

€ 82 016,20

ARTTIC

France

EU Contribution

€ 317 983,80

Project information

Grant agreement ID: 634809

Status

Ongoing project

  • Start date

    1 June 2015

  • End date

    31 May 2020

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 5 994 000,50

  • EU contribution

    € 5 994 000

Coordinated by:

Utrecht University Medical Center

Netherlands