Prof. Truls Myrmel and his team from the University Hospital of North-Norway have received the green light to start recruiting their first patients. This important step for the EURO SHOCK clinical trial on CGS comes after months of intense work. Other institutions will start recruiting in the coming weeks.
The process to approve a recruiting site is led by the clinical trial sponsor, who takes responsibility to initiate, and manage or finance the clinical trial, but does not conduct it. This role in EURO SHOCK is performed by the University of Leicester.
The EURO SHOCK consortium put months of intense work into the preparation of the trial. Common documentation, including consent forms and patient information material, are jointly developed by EURO SHOCK’s ten clinical centres and the sponsor. Each site also has to undergo their country-specific ethical process, which required the translation of the documentation into local languages. The last step in preparation for the trial is the Site Initiation Visit (SIV) to monitor and ensure the site is ready to recruit patients.
Clinical trials: Sponsors and sponsor-investigators. Retrieved on 24.09.2019 from https://learn.marsdd.com/article/clinical-trials-sponsors-and-sponsor-investigators/
Site Initiation Visit (SIV). Retrieved on 24.09.2019 from https://www.nbt.nhs.uk/research-innovation/running-your-study/site-initiation-visit-siv
The EURO SHOCK trial includes the main cardiovascular hospitals in nine European countries. UPC is participating in the project with CardioSense, a device that provides an early cardiovascular diagnosis in less than 60 seconds.
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On 12th December 2018 investigators gathered at the Royal Society of Medicine in London for the last preparations before the trial begins. The recruitment target is to randomise more than 400 patients in 34 months starting from 1st February 2019.
Twelve university hospitals set up pan-European recruiting network with more than 45 cardiovascular centres to test early ECMO in patients with cardiogenic shock once and for all
An extensive network of the foremost cardio-vascular hospitals from nine European countries are working together in the EURO SHOCK trial to determine the efficacy and cost benefit of very early ECMO in patients with cardiogenic shock. On 12th December 2018 investigators gathered at the Royal Society of Medicine in London for the last preparations before the trial begins. The recruitment target is to randomise more than 400 patients in 34 months starting from 1st February 2019.
Every year across Europe more than 50’000 patients are diagnosed with Cardiogenic Shock. Women and the elderly are at highest risk to this severe condition, which is a complex and hemodynamically diverse state of end-organ hypoperfusion.
On 12th December 2018, EURO SHOCK will be having the official kick-off meeting for all its European recruitment centres. The meeting will take place from 10AM - 4PM (UK Time) at the Royal Society of Medicine Wimpole Street in London, UK. For delegates arriving one day before, there will be a joint dinner near the conference venue.
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Registrations for the meeting have closed on Monday 3rd December 2018 at noon.
Thank you for your overwhelming support and interest! All registered for the meeting have received a confirmation email.
We are looking forward to welcoming all in London and should you have any questions in the meantime concerning the event, please write the EURO SHOCK Dissemination Manager Ms. Isabel Sørensen on firstname.lastname@example.org
After months of hard work, the EURO SHOCK Trial has now successfully received Sponsor Approval for study documentation. This means that the process of obtaining regulatory and ethics approval in the participating countries can start. Today, the Principle Investigators (PIs) of all national recruiting networks at Beneficiaries have received all necessary documents to proceed with this.
We are excited to follow the process and start recruitment in the beginning of 2019!
In the middle of the trial set-up we are pleased to announce that we are expanding our recruitment network to include more high-calibre recruiting centres in Belgium and Germany as well as one in Austria! Please have a look at the newly updated webpage with details of all recruiting centres involved in EURO SHOCK.
It is with great pleasure that we welcome the new Senior Trial Manager of EURO SHOCK Ms. Saeeda Bashir to the team.
Based at the University Hospitals of Leicester, Ms. Saeeda Bashir will be responsible for overseeing the management of the EURO SHOCK multi-centre International Randomised Trial involving seven European Union member states and multiple European participating sites. With a track-record of successfully developing and delivering of multi-centre clinical trials and her experience in providing leadership, project and trial management expertise to maintain the smooth and effective running of the clinical trial, we are confident that she will contribute to deliver this trial in accordance with the study protocols, ethics and regulatory approvals, SOPs, GCP principles, EU Directives and UK legislation to the highest level of research governance.
On behalf of all partners in EURO SHOCK, we are looking forward to welcome Ms. Bashir to the team and looking forward to working with her.
New Horizon 2020 EURO SHOCK study sets out to improve the outcome for patients with cardiogenic shock
The new EURO SHOCK study is to receive € 6.5 million from the EU, to assess a new procedure of treatment approach for patients suffering cardiogenic shock. The project unites the foremost physicians in cardio-vascular medicine from across Europe, and is determined to become a bench-mark study on one of the few last challenges in this field. The ambition for EURO SHOCK is nothing less than to reduce the mortality associated with cardiogenic shock – a life threatening condition following a severe coronary heart attack.
Cardio-vascular diseases are responsible for more than 4 million deaths across Europe every year. Overall this type of disease is estimated to cost the European economy € 210 billion a year. Acute myocardial infarction, also more commonly known as heart attacks, evolve in about 10% of all cases into cardiogenic shock (in Europe 60.000-70.000 cases per year) with a 50% mortality rate in the first 30 days. This number is even higher in women and elderly patient groups.
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