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TENSION SIGNED

Efficacy and safety of thrombectomy in stroke with extended lesion and extended time window: a randomized, controlled trial

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

TENSION project word cloud

Explore the words cloud of the TENSION project. It provides you a very rough idea of what is the project "TENSION" about.

clinical central evaluation health functional safety gender training trials countries burden investigators array groups trial cooperation healthcare 714 modified therapeutic post outcome socio reported dependency excluded ordinal blinded rankin rely judgement probe prospective lab reduce images lesion extended patients societal window treatment primary core strives mrs organization linear endpoint principles intervention individual effectiveness economic outcomes image performed prom beneficial ing society randomized involve patient label time tension acquired enroll safer measured successful difference innovative square presenting standards death shift chi eight stroke efficacy days ischemic subjects severe thrombectomy lesions guideline network

Project "TENSION" data sheet

The following table provides information about the project.

Coordinator	UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF Organization address address: Martinistrasse 52 city: HAMBURG postcode: 20251 website: www.uke.uni-hamburg.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	Germany [DE]
Project website	http://www.tension-study.eu
Total cost	5˙990˙684 €
EC max contribution	5˙990˙684 € (100%)
Programme	1. H2020-EU.3.1.3. (Treating and managing disease)
Code Call	H2020-SC1-2017-Two-Stage-RTD
Funding Scheme	RIA
Starting year	2018
Duration (year-month-day)	from 2018-01-01 to 2022-12-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF Organization address address: Martinistrasse 52 city: HAMBURG postcode: 20251 website: www.uke.uni-hamburg.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (HAMBURG)	coordinator	981˙718.00
2	UNIVERSITATSKLINIKUM HEIDELBERG UNIVERSITATSKLINIKUM HEIDELBERG Organization address address: IM NEUENHEIMER FELD 672 city: HEIDELBERG postcode: 69120 website: www.klinikum.uni-heidelberg.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (HEIDELBERG)	participant	2˙331˙208.00
3	EPPDATA GMBH EPPDATA GMBH Organization address address: MEHLBEERWEG 10 city: HAMBURG postcode: 22391 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (HAMBURG)	participant	464˙750.00
4	ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK Organization address address: 5 RUE WATT city: PARIS postcode: 75013 website: www.ecrin.org contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	409˙331.00
5	OSLO UNIVERSITETSSYKEHUS HF OSLO UNIVERSITETSSYKEHUS HF Organization address address: KIRKEVEIEN 166 TARNBYGGET city: OSLO postcode: 450 website: http://www.oslo-universitetssykehus.no contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NO (OSLO)	participant	394˙510.00
6	REGION STOCKHOLM REGION STOCKHOLM Organization address address: HANTVERKARGATAN 45 city: STOCKHOLM postcode: 104 22 website: www.sll.se contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	SE (STOCKHOLM)	participant	248˙375.00
7	HOSPICES CIVILS DE LYON HOSPICES CIVILS DE LYON Organization address address: QUAI DES CELESTINS 3 city: LYON postcode: 69002 website: www.chu-lyon.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (LYON)	participant	237˙653.00
8	AARHUS UNIVERSITETSHOSPITAL AARHUS UNIVERSITETSHOSPITAL Organization address address: PALLE JUUL-JENSENS BOULEVARD 99 city: AARHUS postcode: 8200 website: http://www.en.auh.dk/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DK (AARHUS)	participant	212˙787.00
9	CENTRE HOSPITALIER UNIVERSITAIRE DE REIMS CENTRE HOSPITALIER UNIVERSITAIRE DE REIMS Organization address address: 45 RUE COGNACQ JAY city: REIMS CEDEX postcode: 51092 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (REIMS CEDEX)	participant	142˙125.00
10	MEDIZINISCHE UNIVERSITAT INNSBRUCK MEDIZINISCHE UNIVERSITAT INNSBRUCK Organization address address: CHRISTOPH PROBST PLATZ 1 city: INNSBRUCK postcode: 6020 website: www.i-med.ac.at contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	AT (INNSBRUCK)	participant	142˙125.00
11	UNIVERZITA KOMENSKEHO V BRATISLAVE UNIVERZITA KOMENSKEHO V BRATISLAVE Organization address address: SAFARIKOVO NAM 6 city: BRATISLAVA postcode: 814 99 website: http://www.uniba.sk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	SK (BRATISLAVA)	participant	117˙125.00
12	EUROPEAN SOCIETY OF MINIMALLY INVASIVE NEUROLOGICAL THERAPY EUROPEAN SOCIETY OF MINIMALLY INVASIVE NEUROLOGICAL THERAPY Organization address address: SEEFELDSTRASSE 88 city: ZURICH postcode: 8008 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CH (ZURICH)	participant	92˙100.00
13	INTERNATIONAL CONSORTIUM FOR HEALTHOUTCOMES MEASUREMENT INC. INTERNATIONAL CONSORTIUM FOR HEALTHOUTCOMES MEASUREMENT INC. Organization address address: 14 ARROW STREET SUITE 11 city: CAMBRIDGE MA postcode: 2215 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	US (CAMBRIDGE MA)	participant	78˙375.00
14	STROKE ALLIANCE FOR EUROPE STROKE ALLIANCE FOR EUROPE Organization address address: RUE WASHINGTON 40 city: BRUSSELS postcode: 1050 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (BRUSSELS)	participant	78˙375.00
15	FAKULTNI NEMOCNICE HRADEC KRALOVE FAKULTNI NEMOCNICE HRADEC KRALOVE Organization address address: SOKOLSKA 581 city: HRADEC KRALOVE postcode: 500 05 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CZ (HRADEC KRALOVE)	participant	60˙125.00

Map

Project objective

TENSION (efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time window: a randomized, controlled trial) strives at providing innovative treatment to patients with severe stroke to reduce the individual and societal burden of death and dependency from stroke. To this end, TENSION is a randomized, controlled, prospective, open label, blinded endpoint (PROBE) trial of thrombectomy in stroke patients with extended ischemic stroke lesions and patients presenting in a late time window, who are currently excluded from available effective treatment approaches. The trial will enroll up to 714 subjects in eight European countries. The primary endpoint is functional outcome at 90 days post-stroke measured by the Modified Rankin Scale. The primary effectiveness endpoint analysis is a chi-square test of the difference in linear trends in ordinal mRS outcomes between treatment groups (“mRS shift analysis”). Outcome evaluation will involve a comprehensive array of clinical and safety parameters, health and socio-economic outcomes including patient reported outcome measures (PROM) for evaluation according to the principles of value-based healthcare. Health economic evaluation with cost-effectiveness analysis will be performed and gender-effects on treatment and outcome will be studied. Trial organization will rely on a network of experienced partners with successful cooperation in previous EU-funded stroke trials. An image core lab will provide central judgement of all images acquired within the trial. Standards of image judgement and intervention will be defined and trial specific training will be provided to all investigators. TENSION addresses a major health problem and will provide evidence for more effective and safer therapeutic intervention for patients with severe stroke resulting in improved guideline development, better individual patient outcomes and beneficial effects for the society at large by reduction of stroke-related costs.

Deliverables

List of deliverables.
Procedural standards for thrombectomy in TENSION	Documents, reports	2020-03-18 19:02:56
Project website online (report)	Websites, patent fillings, videos etc.	2020-03-18 19:02:56
Illustrated handbook of image evaluation	Documents, reports	2020-03-18 19:02:56

Take a look to the deliverables list in detail: detailed list of TENSION deliverables.

Publications

List of publications.
year	authors and title	journal	last update
2018	Martin Bendszus, Susanne Bonekamp, Eivind Berge, Florent Boutitie, Patrick Brouwer, Elke Gizewski, Antonin Krajina, Laurent Pierot, Gary Randall, Claus Z. Simonsen, Kamil ZeleÅˆÃ¡k, Jens Fiehler, GÃ¶tz Thomalla A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window published pages: 87-93, ISSN: 1747-4930, DOI: 10.1177/1747493018798558	International Journal of Stroke 14/1	2020-03-18
2019	Martin Bendszus, Jens Fiehler, GÃ¶tz Thomalla New Interventional Stroke Trials published pages: 1-1, ISSN: 1869-1439, DOI: 10.1007/s00062-019-00763-7	Clinical Neuroradiology 29/1	2020-03-18

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The information about "TENSION" are provided by the European Opendata Portal: CORDIS opendata.