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Dear all,

I am very pleased to welcome you back to our first COPE newsletter after the summer break. I hope that you had a lovely time off with your family and loved ones.

COPE has not been idle during the summer and we have very good news to share: the EU Commission has officially approved our amendment request! Thanks to this amendment, COPE is now running for a total of 5.5 years until June 2018 allowing us to balance out the regulatory hurdles and delays encountered when setting up our clinical trials. With the project extension, we can now be confident that recruitment will be completed for all trials and the last patient's follow-up data can be fully collected for analysis. The amendment also implements further changes such as the move of our Work Package 5 leadership to the University Clinic Essen. In light of this approval, we have updated our website and all further communication materials. If you would like to receive more information on our amendment changes, please feel free to get in touch with the project office anytime. 

COMPARE and POMP continue recruitment and the Royal Free Hospital (London, UK) joined POMP as of 1st August 2016. We are also very pleased to announce that the site initiation visits at our new POMP partner sites  Semmelweis University (Budapest, HU) and Hammersmith Hospital (London, UK) are scheduled for end of September. I would like to very warmly welcome the Hammersmith and Semmelweis teams to our POMP trial. Do you want to find out more about our ongoing activities? Just scroll down and enjoy the read!

With best wishes,

WP2 - Normothermic machine perfusion trial

  • The WP2 preliminary results were presented at the 26th International Congress of the Transplantation Society in Hong Kong on 20 August and were very well received (see image).
  • The results were also highlighted in the TTS Press Conference and included in the final TTS plenary session "What Changes Will We See in Transplantation over the next Five Years?"
  • It is now just over six months since the last patient was enrolled in the trial. The six-month data lock is planned for 23:59 on Monday 24th October 2016. Please could all sites ensure that all six-month follow-up data, including MRCP scans, has been recorded prior to this time.
  • The COPE trial radiologists have been confirmed as: Prof John Karani (King’s College Hospital, London), Dr Sara Upponi (Addenbrooke’s Hospital, Cambridge) and Dr Arvind Pallan (Queen Elizabeth Hospital, Birmingham) – many thanks to all three for agreeing to undertake the important task of reviewing the trial MRCP scans.

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

  • The WP Leader Essen has transplanted the 100th POMP kidney on 20 September 2016. Congratulations to the POMP team for reaching this milestone!
  • As of 21 September 2016, POMP has randomised a total of 117 kidneys with 100 kidneys active in the trial.  
  • The site initiation visit for the Semmelweis University in Budapest (HU) will be attended by Peri Kocabayoglu (Essen, DE) and Ally Bradley (Oxford, UK) and is scheduled for 26 and 27 September 2016. The POMP team is very excited to welcome Budapest on board. With about 200 kidney transplants per year, the recruitment for POMP will likely be high.
  • The Royal Free Hospital (London, UK) joined the POMP trial as of 1 August 2016. The first Royal Free kidney was randomised not long after that date and patient consent was taken. However, the patient withdrew consent shortly before the surgery and the kidney was therefore not included in the trial after all. However, we would like to congratulate the team on this speedy randomisation! 
  • The Hammersmith Hospital (London, UK) as well as the Charite Berlin (DE) are due to join the POMP study in the upcoming weeks once a date for the site initiation visit has been found. 

WP4 - COMPARE Trial: oxygenated HMP of DCD kidneys

  • As of 16 September 2016, WP4 has randomised 129 donor pairs, of which 67 pairs have been included in the trial. With a trial target of 99 pairs, this constitutes 67.7% of the overall trial recruitment. Some randomised pairs are lost, particularly if one kidney is declined at the recipient centre or if a kidney is allocated to a country outside of the COMPARE zone.  
  • A very good pace was observed in recent weeks and the COMPARE team would like to thank all involved transplant centres for making this happen.  
  • The COMPARE teams in Belgium, The Netherlands and in the UK are busy gathering the follow-up data for all patients. Collecting robust follow-up data is particularly important in this trial, as the primary end-point is only reached at one year. If included patients don't reach the one year follow-up date, a higher recruitment target has to be introduced to ensure the trial is well-powered. For that purpose, the COMPARE leader in Leuven (BE) is continuously monitoring the drop-out rate in the trial's follow-up period. 

WP5 & WP6 - Experimental work programmes

  • For WP5, the team in Essen (DE) will now take over the experimental work from the partner Bonn. Essen is currently getting set-up as the new WP5 leader and is also awaiting the Animal Ethics Committee approval to start work on the new protocols. 
  • For WP6, the new experimental protocols have been agreed by all involved partners and the team in Poitiers (FR) is getting ready to start work with the Kidney Assist machine disposables delivered and training received.

WP7 - Biobank

  • All formalin fixed samples are now embedded in paraffin blocks and embedding is taking place continuously as new samples are brought to the Oxford central COPE biobank. 
  • Futhermore, all WP2 perfusate and blood samples have been aliquotted over the summer and the COPE Biobank Manager will move on to aliquotting the urine samples as well as the other trials' blood samples. 
  • A sample shipment is scheduled for 17 October 2016 from the continental sites. Please prepare your samples on the WP7 database and ensure that the correct format is used for the Box ID. Please create shipment lists as this forms the storage details of the samples when they arrive in the Central Bio-repository in Oxford.
  • If you need any supplies for sample collection as a participating site, please get in touch. 
  • The biobank logistics for our new POMP partners in Berlin (DE) and Budapest (HU) have been arranged. This includes shipping sample collection boxes, biopsy guns and sample storage boxes to our new partners, ensuring DHL sample shipment arrangements to receive their collections back in Oxford and training the local teams on sample collection during the site initiation visits. 
  • For WP2, sample collection is complete since March 2016 and in the last sample transport from the Continent, the central COPE biobank received all WP2 samples in the Oxford freezers. Based on that, the WP2 and WP7 teams are discussing the upcoming steps for sample analysis including the proteomics analysis as part of our COPE core deliverables towards the EU Commission as well as sample hand-out for ancillary research proposals.  
  • As part of the WP2 - WP7 sample analysis, two research collaborations were agreed to ensure that all raised research questions can be answered based on the limited sample material available. These collaborations revolve around bile duct related research as well as ischemia reperfusion injury and histology related research questions. 

WP8 - Trial design and methodology

no current news

WP9 - Communication and dissemination

  • In light of the recently approved project amendment, all communication materials have been adapted to the change in partnership, change in WP5 leadership and change in project duration. This includes an update to the COPE website as well as new flyers.
  • If you would like to receive the new flyer prints for an upcoming event at your institution, please let the COPE project office know. 
New COPE partnership map after the 2nd amendment. 

WP10 - Management

  • The 2nd COPE amendment was approved by the EU Commission on 16 July 2016. The following changes to the project have now come into effect:
  1. Additional year of project implementation until June 2018;
  2. Termination of partner Bonn due to Professor Minor's move to Essen (DE);
  3. New WP5 leadership now held by the University Clinic Essen (DE);
  4. Small administrative changes such as new legal representatives in partner institutions. 
  • The new project duration also pushes back the milestone and deliverable timelines in the COPE Technical Annex. The Project Office has emailed all Work Package leaders individually informing them of their new timelines for submission to the EU. 
  • The 2nd COPE interim report covering the time frame from July 2014 until December 2015 has been fully approved by the EU Commission and partner payments have been distributed according to each partners' reporting volume. 
  • The COPE Annual Meeting 2017 dates have been fixed for Thu, 6 and Fri, 7 April 2017. More information on the next Annual Meeting will follow in due course. 
Copyright © 2016  COPE  All rights reserved.
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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.

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University of Oxford · Churchill Hospital · Oxford Transplant Centre · Oxford, Oxfordshire OX3 7LE · United Kingdom

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