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Dear all,

We have exciting news to share in this newsletter edition: our COPE liver trial has transplanted its 220th liver on 9 March 2016 at the Queen Elizabeth Hospital in Birmingham completing our trial's target! I would like to very warmly thank the entire WP2 team here in Oxford and at our collaborating centres in the UK and on the Continent for this achievement. To put things in perspective: the first WP2 patient was recruited end of June 2014 creating a total recruitment phase of only 19 months. This could not have been accomplished without the outstanding commitment of all team members involved.  

Furthermore, COPE was represented at the BTS congress in Glasgow with a project booth and an e-poster. We had very interesting sessions and were able to catch up with our many partners and collaborators from the UK and the Continent. Do you want to find out more about our activities over the last two months? Just scroll down and enjoy the read!

With best wishes,

WP2 - Normothermic machine perfusion trial

  • It is with great pleasure that we can confirm that recruitment into the COPE WP2 trial is now complete!
  • This achievement was only made possible by the fantastic level of engagement from all sites – many thanks from the whole COPE team to everyone involved for all your hard work!
  • Please could all sites now shift their focus to ensure that data collection is as complete as possible.
  • A recent protocol amendment means that initial data analysis can start from 30 days after the last liver was transplanted. Therefore a data lock is planned for 11th April.
  • Please ensure that all required data up to and including 30 days post-operatively has been collected for all livers by 11th April.
  • Once again, many thanks to everyone for all your hard work – together we can make this trial a great success!
The 220th liver was transplanted on 9th March by Mr Thamara Perera at the Queen Elizabeth Hospital, Birmingham.
In the end, we randomised a total of 334 livers of which 220 reached the primary end-point (100 SCS, 120 NMP). Initially, a two year recruitment period had been foreseen, but thanks to the extraordinary support this trial received, the recruitment target was reached four months earlier! 
The Queen Elizabeth Hospital, Birmingham, was the strongest recruiter with 140 livers randomised of which 105 were transplanted.

WP3 - POMP Trial: oxygenated HMP re-conditioning of ECD kidneys

  • As of 22nd of March 2016, WP3 has a total of 76 transplanted ECD kidneys after randomising a total of 87 kidneys. 
  • A site contract to include the Charite Berlin (BE) is being drafted at the moment
  • For the additional site in Cardiff (UK), a site initiation visit has been scheduled for 14th of April 2016 and Cardiff will be ready to include in WP3 after that date with logistical support provided through Oxford's Transplant Technicians 
  • UCL in Brussels (BE) is currently applying for Ethics and R&D approval 
  • Further sites including Budapest (HU) have also been approached and are investigating their participation in WP3 as we speak 
Building up of the Kidney Assist machine (1)
Building up of the Kidney Assist machine (2)

WP4 - COMPARE Trial: oxygenated HMP of DCD kidneys

  • As of 22nd of March 2016, WP4 has reached 56% of its trial inclusion with a total of 55 DCD kidney pairs over 50 years old transplanted
  • The recruitment rate of the last few months has been very positive and added considerable speed to the trial. At the current rate, recruitment could be finalised by November 2016
  • After careful consideration, the COPE Management Board decided to stop the WP4 trial inclusion in the UK. This decision was based on the very good WP4 progress made on the Continent and machines kept for WP4 in the UK can now be used for the additional POMP trial centres streamlining our activities and efforts. 
WP4 continental team
Continental Transplant Technicians

WP5 & WP6 - Experimental work programmes

  • Our partner in Poitiers (FR) is getting ready to start their experimental work with the Kidney Assist machine disposables delivered and training received 
  • The WP5 and WP6 teams will present their most recent findings at the COPE Annual Meeting and will outline their plans for future experimental work in COPE

WP7 - Biobank

  • Sample collection for the liver trial is now completed and our Biobank Coordinator will create an update on the sample collection performance in WP2 to be presented at the COPE Annual Meeting
  • With WP2 sample collection completed, the formalin samples are reaching the final stages of being processed into formalin fixed paraffin embedded (FFPE) blocks.
  • Continental samples will be transported to Oxford in the week of the COPE Annual Meeting. Could all allocated staff in charge of samples please ensure that samples are logged into the WP7 database and ready for transportation as it will be organised by MedAssist at short notice.
  • Sample shipment from Barcelona to Oxford was delayed until the end of the WP2 recruitment phase. The samples shipment through DHL will be organised to arrive in the Central Bio-resource in April 2016.
  • WP7 furthermore started investigating which WP2 samples will be required to fulfill the core research proposals. Once these samples have been identified based on sample type, storage or processing technique, donor or recipient demographics and / or clinical data points, WP7 will ensure to flag them in the specific biobank database to ensure their availability for research. 

WP8 - Trial design and methodology

The Data Monitoring Committee will get together on 14th of April in Oxford to discuss the recruitment rates in the POMP and COMPARE trial. A full Data Monitoring Committee covering all trials will be held on 4th of July 2016. 

WP9 - Communication and dissemination

  • COPE was represented at the British Transplant Society congress 2016 held in Glasgow. We were particularly honored to be chosen for an e-poster and had some very good discussions at our project booth. In total, three COPE partners had booths at the BTS including Organ Ox Ltd., Organ Assist Products B.V. and ESOT. A pleasure to catch up with our partners and collaborators. You can find some impressions below!   
  • COPE has a new newsletter lay-out allowing for an easier integration of pictures and graphs. Let us know what you think and we can adapt the template for the next edition. 
  • Organ Ox published a press release for the end of the WP2 recruitment. You can read it by clicking here

WP10 - Management

  • COPE has submitted its 2nd interim report to the EU Commission covering the time from July 2014 until December 2015. Many thanks to all the partners for their input. We will inform you once the EU feedback has been received. 
  • The 2nd COPE amendment is underway and the project office is currently gathering the required documentation before submitting the amendment. The amendment will cover the project extension by 12 months, the move from WP5 to our partner in Essen as well as minor administrative changes. 
  • Our 4th COPE Annual Meeting is coming closer and will be held on 12 and 13 April 2016 in Oxford. the respective Work Package leaders have been contacted for their content preparation and we look forward to a productive meeting with our partners. Don't hesitate to contact the project office with any questions you have relating to the annual meeting. 
COPE Annual Meeting - agenda 12 April 2016
COPE Annual Meeting - agenda 13 April 2016
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This project has received funding from the European Union's Seventh Framework Programme for research, technological development and demonstration under grant agreement 305934.