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

Objective

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 800 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-1 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-sized enterprises, and the joint endeavours of this extended team will ensure the successful enrolment of patients at fifty hospitals across 15 countries in Europe.

Call for proposal

FP7-HEALTH-2011-two-stage
See other projects for this call

Coordinator

UNIVERSITATSKLINIKUM ERLANGEN
Address
Maximiliansplatz 2
91054 Erlangen
Germany
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 746 225,62
Administrative Contact
Katrin Faber (Dr.)

Participants (39)

UNIVERSITATSKLINIKUM HEIDELBERG

Participation ended

Germany
EU contribution
€ 600,22
Address
Im Neuenheimer Feld 672
69120 Heidelberg
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Thorsten Brietz (Mr.)
REGION HOVEDSTADEN
Denmark
EU contribution
€ 533 807,51
Address
Kongens Vaenge 2
3400 Hillerod
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Berit Grevstad (Ms.)
THE UNIVERSITY OF EDINBURGH
United Kingdom
EU contribution
€ 1 254 908,08
Address
Old College, South Bridge
EH8 9YL Edinburgh
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Valerie Renton (Ms.)
STROKE ALLIANCE FOR EUROPE
Belgium
EU contribution
€ 49 086,46
Address
Rue Washington 40
1050 Brussels
Activity type
Other
Administrative Contact
Catharina Lindgren (Ms.)
CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Germany
EU contribution
€ 99 641,15
Address
Chariteplatz 1
10117 Berlin
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Eveline Fräßdorf (Ms.)
UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Netherlands
EU contribution
€ 62 282,80
Address
Heidelberglaan 100
3584 CX Utrecht
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Hendrik Bernardus Van Der Worp (Dr.)
EUROPEAN STROKE RESEARCH NETWORK FOR HYPOTHERMIA ASBL
Belgium
EU contribution
€ 378 468,66
Address
Square De Meeus 38/40
1000 Bruxelles
Activity type
Research Organisations
Administrative Contact
Istvan Szabo (Mr.)
UNIVERSITAET LEIPZIG

Participation ended

Germany
EU contribution
€ 94 503,28
Address
Ritterstrasse 26
04109 Leipzig
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Gerhard Fuchs (Mr.)
UNIVERSITA DEGLI STUDI DI ROMA LA SAPIENZA
Italy
EU contribution
€ 239 121,53
Address
Piazzale Aldo Moro 5
00185 Roma
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Franco Necci (Dr.)
UNIVERSITY OF GLASGOW
United Kingdom
EU contribution
€ 476 949,56
Address
University Avenue
G12 8QQ Glasgow
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Joe Galloway (Mr.)
SKANE LANS LANDSTING
Sweden
EU contribution
€ 278 585,65
Address
.
291 89 Kristianstad
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Jesper Petersson (Dr.)
INSTYTUT PSYCHIATRII I NEUROLOGII
Poland
EU contribution
€ 67 094,06
Address
Ulica Sobieskiego 9
02 957 Warszawa
Activity type
Research Organisations
Administrative Contact
Anna Czlonkowska (Prof.)
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

Participation ended

France
EU contribution
€ 12 258,47
Address
Rue De Tolbiac 101
75654 Paris
Activity type
Research Organisations
Administrative Contact
Lyddie Laaland (Ms.)
THE UNIVERSITY OF NOTTINGHAM
United Kingdom
EU contribution
€ 491 794,84
Address
University Park
NG7 2RD Nottingham
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Paul Cartledge (Mr.)
INSTITUT CATALA DE LA SALUT

Participation ended

Spain
Address
Gran Via De Les Corts Catalanes 587
08007 Barcelona
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Carlos Molina (Dr.)
FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA
Spain
EU contribution
€ 459 046,26
Address
Passeig Vall D Hebron 119-129 Edificio De Recerca
08035 Barcelona
Activity type
Research Organisations
Administrative Contact
Estel Gil Guiñon (Dr.)
TECHNISCHE UNIVERSITAET DRESDEN

Participation ended

Germany
EU contribution
€ 33 841,68
Address
Helmholtzstrasse 10
01069 Dresden
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Carsten Glück (Mr.)
UNIVERSITE PARIS XII VAL DE MARNE
France
EU contribution
€ 91 201,34
Address
Avenue Du General De Gaulle 61
94010 Creteil
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Nicolas Vautrin (Mr.)
ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Italy
EU contribution
€ 57 795,35
Address
Via Mario Negri 2
20156 Milano
Activity type
Research Organisations
Administrative Contact
Maria Grazia Pezzoni (Ms.)
VARSINAIS-SUOMEN SAIRAANHOITOPIIRIN KUNTAYHTYMA
Finland
EU contribution
€ 149 578,11
Address
Kiinamyllynkatu 4-8
20520 Turku
Activity type
Research Organisations
Administrative Contact
Arja Pesonen (Ms.)
CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE LILLE
France
EU contribution
€ 303 040,87
Address
Avenue Oscar Lambret 2
59037 Lille
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Guillaume Tueux (Mr.)
ALGEMEEN ZIEKENHUIS SINT-JAN BRUGGE-OOSTENDE AUTONOME VERZORGINSINSTELLING
Belgium
EU contribution
€ 178 043,31
Address
Ruddershove 10
8000 Brugge
Activity type
Research Organisations
Administrative Contact
Valerie Schotte (Ms.)
GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG

Participation ended

Germany
EU contribution
€ 160 288,99
Address
Oskar Von Miller Ring 29
80333 Muenchen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Birgit Fuchs (Ms.)
QUICK COOL AB
Sweden
EU contribution
€ 98 095,96
Address
Scheelevagen Beta 6 Ideon Science Park 17
22370 Lund
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Christer Jacobsson (Mr.)
EMCOOLS - MEDICAL COOLING SYSTEMS AG
Austria
EU contribution
€ 69 367,28
Address
Brucknerstrasse 6/7 A
1040 Wien
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Michael Kühling (Mr.)
ELVIDO MEDICAL TECHNOLOGY SRL

Participation ended

Italy
Address
Viale Della Vittoria 214
31029 Vittorio Veneto Tv
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Elmar Landwehr (Mr.)
Electrophoretics Ltd
United Kingdom
EU contribution
€ 31 441,06
Address
Coveham House Downside Bridge Road
KT113EP Cobham
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
James Malthouse (Mr.)
Randox Clinics Limited
United Kingdom
EU contribution
€ 30 285,16
Address
Diamond Road 34
BT29 4QY Crumlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Catherine Laird (Ms.)
FLOWLAB PROYECTOS DE INNOVACION SL

Participation ended

Spain
EU contribution
€ 16 397,38
Address
Avenida De La Torreblanca 57 1 A 4 Esadecreapolis
08173 Sant Cugat Del Valles
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Federico Degispert (Mr.)
NATIONAL STROKE RESEARCH INSTITUTE
Australia
Address
Burgundy St 245
3084 Heidelberg
Activity type
Research Organisations
Administrative Contact
Henry De Aizpurua (Mr.)
HACETTEPE UNIVERSITESI
Turkey
EU contribution
€ 64 775,32
Address
Hacettepe Universitesi Beytepe Kampusu Rektorluk Binasi
06800 Cankaya Ankara
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Serpil Sevtap Benli (Ms.)
DIMOKRITIO PANEPISTIMIO THRAKIS

Participation ended

Greece
Address
Panepistimioupoli Rectorate Building
69100 Komotini
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Georgios Tsivgoulis (Dr.)
VIESOJI ISTAIGA VILNIAUS UNIVERSITETO LIGONINE SANTAROS KLINIKOS
Lithuania
EU contribution
€ 63 093,42
Address
Santariskiu G 2
08661 Vilnius
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Liuda Grigentienė (Ms.)
TARTU ULIKOOL

Participation ended

Estonia
EU contribution
€ 811,24
Address
Ulikooli 18
51005 Tartu
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Janika Kõrv (Dr.)
MEDIZINISCHE UNIVERSITAT INNSBRUCK

Participation ended

Austria
EU contribution
€ 2 559,12
Address
Christoph Probst Platz 1
6020 Innsbruck
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Sonja Schmidl (Dr.)
INSERM TRANSFERT SA
France
EU contribution
€ 143 439,34
Address
Rue Watt 7
75013 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Louis Jammayrac (Mr.)
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
EU contribution
€ 184 892,90
Address
5 Rue Watt
75013 Paris
Activity type
Research Organisations
Administrative Contact
Alicja Szofer-Araya (Mrs.)
FAKULTNI NEMOCNICE U SV. ANNY V BRNE
Czechia
EU contribution
€ 79 171,71
Address
Pekarska 53
656 91 Brno
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Romana Prudilová (Mrs.)
BORD OSPIDEIL NAOIMH SHEAMUIS
Ireland
EU contribution
€ 79 171,71
Address
James S Street
8 Dublin
Activity type
Research Organisations
Administrative Contact
Carol Murphy (Ms.)