Skip to main content
European Commission logo print header

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

Objetivo

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.

Convocatoria de propuestas

H2020-PHC-2014-2015

Consulte otros proyectos de esta convocatoria

Convocatoria de subcontratación

H2020-PHC-2014-two-stage

Régimen de financiación

RIA - Research and Innovation action

Coordinador

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Aportación neta de la UEn
€ 1 464 373,25
Dirección
HEIDELBERGLAAN 100
3584 CX Utrecht
Países Bajos

Ver en el mapa

Región
West-Nederland Utrecht Utrecht
Tipo de actividad
Higher or Secondary Education Establishments
Enlaces
Coste total
€ 1 464 373,75

Participantes (19)