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.
Fields of science
- medical and health scienceshealth sciencesnursing
- medical and health sciencesclinical medicinepneumology
- medical and health sciencesclinical medicineendocrinologydiabetes
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsantibiotics
- medical and health sciencesbasic medicineneurologystroke
Programme(s)
Topic(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
3584 CX Utrecht
Netherlands
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Participants (19)
NG7 2RD Nottingham
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0450 Oslo
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46100 Mantova
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4032 Debrecen
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75013 Paris
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3015 GD Rotterdam
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02 957 Warszawa
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50406 Tartu
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G12 8QQ Glasgow
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EH8 9YL Edinburgh
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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.
EH1 3EG Edinburgh
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20251 Hamburg
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1105AZ Amsterdam
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20251 Hamburg
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
38221 Volos
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1050 Brussels
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Participation ended
80333 Muenchen
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
75008 Paris
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80333 Munchen
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