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Contact Information:

Dr Andrea Schlegel


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

King's College Hospital
London
SE5 9RS


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HOPE for human livers

Medical Conditions

Liver transplantation


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




Background and study aims
The life of many people strictly depends on a new liver. Unfortunately, there are not enough organs for all potential recipients on the waiting list. Livers of lower quality with a higher risk of functional impairment after transplantation therefore have to be used. The aim is therefore to improve the quality and function of such livers. Hypothermic oxygenated perfusion (HOPE) is organ perfusion with a cold perfusion solution with a lot of oxygen. Following routine liver transport in the cold (standard cold storage), livers undergo a short, cold perfusion for 1-2 hours before implantation. The machine used for this has been introduced into the field of liver transplantation and is used in many centres worldwide. A short, cold and oxygenated liver perfusion before transplantation improves the function of the liver in the recipient. These results have been confirmed internationally. The aim of this study is to improve liver function after transplantation by using a short and cold machine perfusion and analyse outcomes and complications after liver transplantation.

Who can participate?
Patients aged 18 or above who are receiving a liver transplant

What does the study involve?
Livers are randomly allocated into two groups to undergo either conventional cold storage or cold storage plus HOPE before implantation. The liver recipients are followed up to assess complications, liver function, length of hospital and ICU stay, and patient and transplant survival at 1 year.

What are the possible benefits and risks of participating?
Participation may improve the function of the new liver and the results will help liver recipients in the future, as more patients will receive a new liver with a better function, outcome and survival in the future. The perfusion solution is produced synthetically, sterile and has not been retrieved from another living organism. Participants are therefore not exposed to a higher risk for transmission of HIV or hepatitis virus infections. During and after the transplant procedure, several blood tests and liver biopsies (samples) are regularly necessary. There are no changes from the standard procedure after liver transplantation during participation in this study. The medical treatment including immunosuppression is not influenced by the study. All liver recipients get standard immunosuppression, with or without participation in the study. The overall risk for participants is very small. Occurrence of unexpected risks is unlikely but cannot be completely excluded. More than 120 livers have been transplanted after this perfusion technique worldwide (in Switzerland, USA, Italy and Netherlands), where no specific unexpected side effects have been reported yet.

Where is the study run from?
The study takes place at University Hospital Zurich (Switzerland) and 8-10 other centres in Europe, for example in Birmingham (QEHB), London (King’s College Hospital) and Edinburgh (UK).

When is the study starting and how long is it expected to run for?
April 2016 to July 2019

Who is funding the study?
Swiss National Science Foundation (Switzerland)

The purpose of this study is, in a phase II randomized trial, to test a newly developed machine perfusion technique of human liver allografts before transplantation. Significance of planned research: Late biliary injury and graft loss remain a major problem in the era of sick liver transplant recipients and marginal donors. Machine liver perfusion techniques have been recognized as potentially protective, but are still not in use in human liver transplantation, because of low practicability and lack of prospective human studies. The suggested study will demonstrate, for the first time worldwide, the effect of an easy and applicable perfusion technique in human liver grafts. The trialists postulate, therefore, a high acceptance rate among transplant surgeons. In case of convincing success, it can be applied at low cost and low resources in any center worldwide.


Multicenter randomized controlled trial

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Apr 2016

01 May 2018

Interventional

Intervention Type : Device
Intervention Description : Randomization will be performed at the time of liver acceptance. This is usually also the time when the liver recipient is admitted to hospital. The liver will be randomized by the local investigator or the trial coordinator using an online randomization tool. A computer-generated list of random assignments (block randomization per center (www.randomizer.at) is prepared in advance. Hence, concealed allocation will not be possible. The timepoint for randomization will be at the end of procurement to assure a minimum dropout of cases. The procurement team will call the local or principal investigator, who coordinates the randomization in that center. The randomization list from the randomizer has been incorporated into the newly developed eCRF. All personnel involved in randomization will be trained in the use of the online randomization by the Project Leader or the Principal Investigator of each site.

Liver grafts from brain death donors (DBD) will be randomly divided in two groups, receiving either conventional cold storage (n=85) according to standard criteria of organ preservation or cold storage plus subsequent hypothermic oxygenated perfusion (HOPE), performed ex-situ with the liver assist device, before implantation (n=85).

Follow up of each included patient will be 12 months.


You can take part if:


1. Candidates for liver transplantation2. Aged 18 or above3. Receiving a whole liver graft4. Full consent for the study




You may not be able to take part if:

1. DCD livers2. Split grafts3. Living donor livers4. Combined grafts5. Domino liver transplantations6. Cold storage of more than 12 hrs


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • King's College Hospital
    London
    SE5 9RS
  • Queen Elizabeth Hospital
    Birmingham
    B15 2TH
  • Royal Infirmary of Edinburgh
    EH16 4SA
  • University Hospital Zurich
    8091
  • Hospital Universitario “Reina Sofia”
    Cordoba
    14004
  • University of Medicine “Carol Davila”
    Fundeni Clinical Institute
    Bucharest
    030167
  • Klinik für Allgemeine und Transplantationschirurgie - University Hospital Essen
    45147
  • Universitaire Ziekenhuizen Leuven
    Abdominal Transplant Surgery
    B-3000
  • Erasmus Medical Centre
    Rotterdam
    3015 CE
  • University Medical Centre Groningen
    9713 GZ

Dr Andrea Schlegel


More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University Hospital Zurich and funded by Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung.



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for Trial ID: ISRCTN15527114

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