After achieving national ethics approval, Steven Haine (UZA) and Tom Adriaenssens (KUL) of our Belgian teams, hosted a successful kick-off event for the participating hospitals in Belgium. Due to the pandemic, the event was held online on 22 April 2021 and was attended by more than 50 participants.
The programme included

• In memoriam Prof A. Gershlick
• Rational for a randomised study on ECMO in cardiogenic shock
• Management of VA-ECMO
• VA-ECMO related complications and caveats
• EURO SHOCK protocol
• Obtaining informed consent of patients in cardiogenic shock
  
• Practical aspects and Q&A on EURO SHOCK.

All Belgian sites are now enthusiastically waiting for Sponsor green light to start patient recruitment.

The UK is no longer part of the EU, but nothing has changed for EURO SHOCK. Our UK-based project coordinator and trial sponsor, the University of Leicester, and our several UK partners recruiting patients confirm that no changes to contracts or other agreements are needed at this time.

The UK announced that the treaty agreed with the EU will ensure the free flow of data from the EU and EEA to the UK until the decision is issued, or for a maximum of six months. This means that EURO SHOCK can rely on the free flow of data from 1 January 2021 and will not have to make any changes to data protection practices.

Source:
Brexit - new EU-UK partnership: where do we stand? Retrieved on 05.01.2021 from NL - Government
UK-EU Trade and Cooperation Agreement. Retrieved on 05.01.2021 from UK - Government
Guidance for health and social care researchers at the end of the Transition Period. Retrieved on 05.01.2021 from NHS - Health Research Authority

Many of you already know, Professor Tony Gershlick died on 20th November 2020 as a result of a COVID-19 infection. Tony initiated the EURO SHOCK Project as Chief Investigator and was the Scientific Coordinator of the EURO SHOCK Research and Innovation Action at the Coordinator University of Leicester. His loss is devastating to all who knew him and the broader medical and scientific community.

After consulting with all Beneficiaries of the EURO SHOCK project and the trial sponsor, all participants have unanimously agreed to keep the project going. The operational management has been re-organised as follows:

• Trial management will be headed by Prof Marcus Flather of the University of East Anglia (UEA). Marcus has been involved in the EURO SHOCK trial management group from the start and has extensive experience of managing multi-centre trials.
  
• Clinical aspects of the trial will be led by Dr Manel Sabaté of the Institut D’Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS). Manel has vast clinical experience and has also been a valuable member of the trial management group.
• The Trial Management Group will continue to meet each week to ensure that the trial moves forward as planned
• The Consortium meets each month to oversee all aspect of the Project
  

Many thanks to Marcus, Manel and everyone involved who have stepped up in this difficult time to ensure the project and trial can move forward.

Please also see our remembrance of Tony from our newsletter.

Our Chief Investigator Prof. Tony Gershlick will chair a case-based conference on the Impact of COVID-19 on Acute Coronary Syndromes. The conference will include an array of clinical cases as well as discussions centred around the indirect impact on cardiovascular disease and trial implications. Two of your PIs, Dr. Martin Orban (LMUM) and Dr. Manel Sabaté (IDIBAPS) will each present one of their recent cases.

Have a look at the detailed programme!

The webinar will be held on 25 November 2020, 10:00-17:00 GMT. You can register for the conference via the Millbrook Medical Conferences website or on Twitter.

Two more patients have been randomised to the EURO SHOCK trial, one each in Spain and Germany! Many thanks to the local teams for their continuous efforts. 
We are also happy that all of our clinical sites that were active pre-COVID-19 are now screening again. This is after they have received green light from their local authorities as well as the study sponsor. 

The first EURO SHOCK patient in Norway was randomised by Truls Myrmel and his team at the University Hospital North Norway. This event also marks another important milestone, as this also is the first patient randomised after the suspension of the study due to the COVID-19 pandemic. 

Our partners in Spain, Germany, Latvia and Norway have re-started their recruitment of patiens after receiving clearance from their local regulators and the study sponsors. This comes after the numbers of COVID-19 cases have considerably lowered in those areas. 

Due to the Covid-19 pandemic, EURO SHOCK is suspending trial recruitment. Our thoughts go to our colleagues and their patients fighting the virus. We are using this time to come back stronger and deliver this important trial.