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Testing the value of a novel strategic approach and its cost efficacy to improve the poor outcomes in Cardiogenic Shock

Deliverables

Health economic analysis in EURO SHOCK

Full report of health economic analysis in EURO SHOCK including recommendations on equity and access if ECMO is found to be cost effective

Cost of health care cost drivers in UK and Germany

Report summarising cost of health care cost drivers in UK and Germany

First study subject approvals package

This deliverable scheduled prior to enrolment of first study subject includes a a final version of study protocol as submitted to regulators ethics committees no need to change deliverable if later amendments b a registration number of clinical study in a WHO or ICMJE approved registry please note result posting for the study must be possible and c approvals ethics committees and national competent authority if applicable required for invitation enrolment of first subject in at least one clinical centre

Standard Operating Procedures

Standard Operating Procedures including 1 the use of ECMO 2 patient informed consent

Trial governance report

Trial governance report, including details of clinical staff contacts, roles and responsibilities of the individ-ual contacts to allow effective communication.

Interim dissemination and outreach report

Interim dissemination and outreach report This report will provide an overview of the activities achieved to date and assess their impact by means of Key Performance Indicators 36 48 60

SOPs for outcome evaluation

SOPs for outcome evaluation Instructions for evaluation procedure

MRI protocol

MRI protocol Report resulting in publication in an imaging speciality journal openaccess to the protocol

Statistical analysis plan

Statistical analysis plan.

MRI pilot study

MRI pilot study Report resulting in publication in a cardiology specialty journal

'Report on status of posting results

This deliverable includes a report on the status of the result posting including timelines when final posting of results is scheduled after the end of the funding period

Dissemination and Outreach Plan (DOP)

Dissemination and Outreach Plan (DOP): Comprehensive DOP with the support of all Partners.

Final report on cardiological outcome

Final report on cardiological outcome Summary of results of short and long term cardiological outcome

Data Safety and Monitoring Board and Ethics Board Report

Data Safety and Monitoring Board and Ethics Board Report

EURO SHOCK website

EURO SHOCK website: Responsive design, new media features, and password protected / secured area for central document storage.

EURO SHOCK scientific symposium

EURO SHOCK scientific symposium A final meeting presenting the study results to clinicians scientists and other expert target groups

Training materials for sites in all relevant health economic aspects

Training materials for sites in all relevant health economic aspects.

Training documents

Training documents in the local languages of all partner site countries, including print and online material.

Publications

Veno-arterial extracorporeal membrane oxygenation (ECMO) in patients with cardiogenic shock: rationale and design of the randomised, multicentre, open-label EURO SHOCK trial

Author(s): Amerjeet Singh Banning, Tom Adriaenssens, Colin Berry, Kris Bogaerts, Andrejs Erglis, Klaus Distelmaier, Giulio Guagliumi, Steven Haine, Adnan Kastrati, Steffen Massberg, Martin Orban, Truls Myrmel, Alain Vuylsteke, Fernando Alfonso, Frans Van de Werf, Freek Verheugt, Marcus Flather, Manel Sabaté, Christiaan Vrints, Anthony H. Gershlick
Published in: EuroIntervention, Issue 16/15, 2021, Page(s) e1227-e1236, ISSN 1969-6213
Publisher: Eurointervention
DOI: 10.4244/eij-d-20-01076

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