European multicentre, randomised, phase III clinical trial of hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke

akronüüm: EUROHYP-1
algus: 2012-02-01
lõpp: 2017-01-31
 
programm: FP7 - Euroopa Liidu 7. raamprogramm
alaprogramm: HEALTH - Tervis
instrument: CP-IP - Suuremahulised integreeritud projektid
projektikonkurss: FP7-HEALTH-2011-two-stage
projekti number: 278709
kestus kuudes: 60
partnerite arv: 36
 
lühikokkuvõte: The consortium led by UKER and EuroHYP, the European Stroke Research Network for Hypothermia, proposes a large, multicentre clinical trial which will assess mild hypothermia as a novel treatment for ischemic stroke. Stroke is the second cause of death world-wide and the second cause of lost disability-adjusted life years in high-income countries. Stroke incidence rises exponentially with age, so its social and economic burden will grow with the ageing of the European population. Current treatment options for the 80 to 85% of all strokes due to cerebral ischaemia - around. 900,000 events in Europe every year, or one every 40 seconds - are extremely limited. Systematic review of experimental studies suggests that hypothermia is the most promising intervention identified to date. Therapeutic cooling is effective in reducing ischaemic brain injury following cardiac arrest, and hypothermia is therefore considered by experts the most promising treatment for patients with acute ischaemic stroke, next to reperfusion strategies. The EuroHYP-1 trial is a pan-European, open, randomised, phase III clinical trial which will assess the benefit or harm of therapeutic cooling in 1500 awake adult patients with acute ischaemic stroke. In addition to efficacy and safety, the economic impact of therapeutic hypothermia will be assessed, along with several sub-studies involving imaging, ultrasound, and biomarker methods. The investigators involved in the EuroHYP consortium are leading European experts in statistical design and analysis, therapeutic hypothermia, imaging, health economics, ultrasound, biomarkers, and trial execution (implementation and monitoring). Moreover – in addition to these academic experts the consortium also involves European patient and family advocacy groups and small and medium-size enterprises, and the joint endeavours of this extended team will ensure the successful enrolment of patients at eighty hospitals across 25 countries in Europe.
partneri jrk nr ja roll partneri nimi riik kontaktisik koduleht
1 koordinaator UNIVERSITAETSKLINIKUM ERLANGEN DE Katrin Faber http://www.uk-erlangen.de
2 partner UNIVERSITAETSKLINIKUM HEIDELBERG DE Thorsten Brietz
3 partner REGION HOVEDSTADEN DK Berit Grevstad http://www.regionh.dk
4 partner THE UNIVERSITY OF EDINBURGH UK Valerie Renton http://www.ed.ac.uk
5 partner STROKE ALLIANCE FOR EUROPE BE Catharina Lindgren
6 partner CHARITE - UNIVERSITAETSMEDIZIN BERLIN DE Eveline Fräßdorf http://www.charite.de
7 partner UNIVERSITAIR MEDISCH CENTRUM UTRECHT NL Hendrik Bernardus Van Der Worp http://www.umcutrecht.nl
8 partner EUROPEAN STROKE RESEARCH NETWORK FOR HYPOTHERMIA ASBL BE Istvan Szabo http://www.eurohyp.org
9 partner UNIVERSITAET LEIPZIG DE Gerhard Fuchs http://www.uni-leipzig.de
10 partner UNIVERSITA DEGLI STUDI DI ROMA LA SAPIENZA IT Franco Necci http://www.uniroma1.it
11 partner UNIVERSITY OF GLASGOW UK Joe Galloway http://www.gla.ac.uk
12 partner SKANE LANS LANDSTING SE Jesper Petersson http://www.skane.se
13 partner INSTYTUT PSYCHIATRII I NEUROLOGII PL Anna Czlonkowska http://www.ipin.edu.pl
14 partner INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) FR Lyddie Laaland http://www.inserm.fr
15 partner THE UNIVERSITY OF NOTTINGHAM UK Paul Cartledge http://www.nottingham.ac.uk
16 partner INSTITUT CATALA DE LA SALUT ES Carlos Molina
17 partner FUNDACIO INSTITUT DE RECERCA DE L'HOSPITAL UNIVERSITARI VALL D'HEBRON ES Lluis Masso http://www.vhebron.es/vhang.htm
18 partner TECHNISCHE UNIVERSITAET DRESDEN DE Carsten Glück
19 partner UNIVERSITE PARIS XII VAL DE MARNE FR Nicolas Vautrin http://www.univ-paris12.fr
20 partner ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI IT Maria Grazia Pezzoni http://www.marionegri.it
21 partner VARSINAIS-SUOMEN SAIRAANHOITOPIIRIN KUNTAYHTYMA FI Arja Pesonen
22 partner CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE LILLE FR Guillaume Tueux
23 partner ALGEMEEN ZIEKENHUIS SINT-JAN BRUGGE-OOSTENDE AUTONOME VERZORGINSINSTELLING BE Valerie Schotte http://www.azbrugge.be
24 partner GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG GAB O DE Birgit Fuchs http://www.gabo-mi.com
25 partner QUICK COOL AB SE Christer Jacobsson http://www.quickcool.se
26 partner EMCOOLS - MEDICAL COOLING SYSTEMS AG AT Michael Kühling http://www.emcools.com
27 partner ELVIDO MEDICAL TECHNOLOGY SRL IT Elmar Landwehr http://www.elvido.eu
28 partner ELECTROPHORETICS LTD UK James Malthouse
29 partner Randox Clinics Limited UK Catherine Laird http://www.randoxtestingservices.com
30 partner FLOWLAB PROYECTOS DE INNOVACION SL ES Federico Degispert http://www.flowlab.biz
31 partner NATIONAL STROKE RESEARCH INSTITUTE AU Henry De Aizpurua http://www.florey.edu.au
32 partner HACETTEPE UNIVERSITESI TR Serpil Sevtap Benli http://www.hacettepe.edu.tr
33 partner DEMOCRITUS UNIVERSITY OF THRACE EL Georgios Tsivgoulis
34 partner VIESOJI ISTAIGA VILNIAUS UNIVERSITETO LIGONINES SANTARISKIU KLINIKOS LT Liuda Grigentienė http://www.santa.lt
35 partner Tartu Ülikool EE Janika Kõrv http://www.ut.ee
36 partner MEDIZINISCHE UNIVERSITAET INNSBRUCK AT Sonja Schmidl http://www.i-med.ac.at