A multicentre randomised controlled trial to compare the efficacy of ex-vivo normothermic machine perfusion with static cold storage in human liver transplantation

doi:10.1038/protex.2018.027

This is a protocol preprint. Preprints are preliminary reports that have not undergone peer review. They should not be considered conclusive, used to inform clinical practice, or referenced by the media as validated information.

Method Article

Biological techniques

A multicentre randomised controlled trial to compare the efficacy of ex-vivo normothermic machine perfusion with static cold storage in human liver transplantation

David Nasralla, Mohammed Zeeshan Akhtar, Ally Bradley, Andrew Butler, Virginia Chiocchia, Susan Dutton, Juan Carlos García-Valdecasas, Charles Imber, Wayel Jassem, Simon Knight, Hynek Mergental, Andreas Paul, Jacques Pirenne, Rutger Ploeg, Constantin C Coussios, Peter J Friend

David Nasralla

Consortium for Organ Preservation in Europe and Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK

Corresponding Author

Mohammed Zeeshan Akhtar

Nuffield Department of Surgical Sciences, University of Oxford, UK

Ally Bradley

Nuffield Department of Surgical Sciences, University of Oxford, UK

Andrew Butler

University of Cambridge Department of Surgery, Addenbrooke’s Hospital, Cambridge, UK

Virginia Chiocchia

Surgical Intervention Trials Unit, Nuffield Department of Surgical Sciences, University of Oxford, UK

Susan Dutton

Centre for Statistics in Medicine, University of Oxford, UK

Juan Carlos García-Valdecasas

Hospital Clinic, University of Barcelona, Spain

Charles Imber

Department of Hepatopancreatobiliary and Liver Transplant Surgery, Royal Free Hospital, London, UK

Wayel Jassem

Institute of Liver Studies, King's College Hospital, London, UK

Simon Knight

Nuffield Department of Surgical Sciences, University of Oxford, UK

Hynek Mergental

Queen Elizabeth Hospital Birmingham, Birmingham, UK

Andreas Paul

Department of General, Visceral and Transplantation Surgery, University Hospital Essen, Essen, Germany

Jacques Pirenne

Abdominal transplant surgery, Department of Surgery, University Hospitals Leuven, Leuven, Belgium

Rutger Ploeg

Consortium for Organ Preservation in Europe and Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK

Constantin C Coussios

Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, UK

Peter J Friend

Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK

DOI:

10.1038/protex.2018.027

License:

This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License

The global organ shortage has necessitated the use of increasingly marginal livers for transplantation. The current standard method of liver preservation, static cold storage (SCS), is not suitable for many marginal organs, increasing the risk of significant complications or graft failure. Normothermic machine perfusion (NMP) enables the liver to be preserved in a functioning physiological state. Previous animal studies suggest this may improve the quality of organs after transplantation. This protocol relates to the first multi-national, randomised controlled clinical trial to directly compare SCS with NMP in human liver transplantation.

Keywords

clinical trial; liver transplantation; organ preservation; normothermic perfusion

Please see attached trial protocol for details

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NMP vs SCS Clinical Trial Protocol A multicentre randomised controlled trial to compare the efficacy of ex-vivo normothermic machine perfusion with static cold storage in human liver transplantation

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Method Article

Biological techniques

A multicentre randomised controlled trial to compare the efficacy of ex-vivo normothermic machine perfusion with static cold storage in human liver transplantation

David Nasralla, Mohammed Zeeshan Akhtar, Ally Bradley, Andrew Butler, Virginia Chiocchia, Susan Dutton, Juan Carlos García-Valdecasas, Charles Imber, Wayel Jassem, Simon Knight, Hynek Mergental, Andreas Paul, Jacques Pirenne, Rutger Ploeg, Constantin C Coussios, Peter J Friend

David Nasralla

Consortium for Organ Preservation in Europe and Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK

Corresponding Author

Mohammed Zeeshan Akhtar

Nuffield Department of Surgical Sciences, University of Oxford, UK

Ally Bradley

Nuffield Department of Surgical Sciences, University of Oxford, UK

Andrew Butler

University of Cambridge Department of Surgery, Addenbrooke’s Hospital, Cambridge, UK

Virginia Chiocchia

Surgical Intervention Trials Unit, Nuffield Department of Surgical Sciences, University of Oxford, UK

Susan Dutton

Centre for Statistics in Medicine, University of Oxford, UK

Juan Carlos García-Valdecasas

Hospital Clinic, University of Barcelona, Spain

Charles Imber

Department of Hepatopancreatobiliary and Liver Transplant Surgery, Royal Free Hospital, London, UK

Wayel Jassem

Institute of Liver Studies, King's College Hospital, London, UK

Simon Knight

Nuffield Department of Surgical Sciences, University of Oxford, UK

Hynek Mergental

Queen Elizabeth Hospital Birmingham, Birmingham, UK

Andreas Paul

Department of General, Visceral and Transplantation Surgery, University Hospital Essen, Essen, Germany

Jacques Pirenne

Abdominal transplant surgery, Department of Surgery, University Hospitals Leuven, Leuven, Belgium

Rutger Ploeg

Consortium for Organ Preservation in Europe and Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK

Constantin C Coussios

Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, UK

Peter J Friend

Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK

Version History

CURRENT STATUS: Posted

Version 1

Posted 14 May, 2018

MetricsComments: 0HTML Views: ...

Subject Areas

Biological techniques

DOI:

10.1038/protex.2018.027

License:

This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License

Please see attached trial protocol for details

This is a protocol preprint. Preprints are preliminary reports that have not undergone peer review. They should not be considered conclusive, used to inform clinical practice, or referenced by the media as validated information.

Method Article

Biological techniques

A multicentre randomised controlled trial to compare the efficacy of ex-vivo normothermic machine perfusion with static cold storage in human liver transplantation

David Nasralla, Mohammed Zeeshan Akhtar, Ally Bradley, Andrew Butler, Virginia Chiocchia, Susan Dutton, Juan Carlos García-Valdecasas, Charles Imber, Wayel Jassem, Simon Knight, Hynek Mergental, Andreas Paul, Jacques Pirenne, Rutger Ploeg, Constantin C Coussios, Peter J Friend

David Nasralla

Consortium for Organ Preservation in Europe and Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK

Corresponding Author

Mohammed Zeeshan Akhtar

Nuffield Department of Surgical Sciences, University of Oxford, UK

Ally Bradley

Nuffield Department of Surgical Sciences, University of Oxford, UK

Andrew Butler

University of Cambridge Department of Surgery, Addenbrooke’s Hospital, Cambridge, UK

Virginia Chiocchia

Surgical Intervention Trials Unit, Nuffield Department of Surgical Sciences, University of Oxford, UK

Susan Dutton

Centre for Statistics in Medicine, University of Oxford, UK

Juan Carlos García-Valdecasas

Hospital Clinic, University of Barcelona, Spain

Charles Imber

Department of Hepatopancreatobiliary and Liver Transplant Surgery, Royal Free Hospital, London, UK

Wayel Jassem

Institute of Liver Studies, King's College Hospital, London, UK

Simon Knight

Nuffield Department of Surgical Sciences, University of Oxford, UK

Hynek Mergental

Queen Elizabeth Hospital Birmingham, Birmingham, UK

Andreas Paul

Department of General, Visceral and Transplantation Surgery, University Hospital Essen, Essen, Germany

Jacques Pirenne

Abdominal transplant surgery, Department of Surgery, University Hospitals Leuven, Leuven, Belgium

Rutger Ploeg

Consortium for Organ Preservation in Europe and Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK

Constantin C Coussios

Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, UK

Peter J Friend

Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK

DOI:

License:

This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License

Abstract

Keywords

clinical trial; liver transplantation; organ preservation; normothermic perfusion

Procedure

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Method Article

Biological techniques

A multicentre randomised controlled trial to compare the efficacy of ex-vivo normothermic machine perfusion with static cold storage in human liver transplantation

David Nasralla, Mohammed Zeeshan Akhtar, Ally Bradley, Andrew Butler, Virginia Chiocchia, Susan Dutton, Juan Carlos García-Valdecasas, Charles Imber, Wayel Jassem, Simon Knight, Hynek Mergental, Andreas Paul, Jacques Pirenne, Rutger Ploeg, Constantin C Coussios, Peter J Friend

David Nasralla

Consortium for Organ Preservation in Europe and Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK

Corresponding Author

Mohammed Zeeshan Akhtar

Nuffield Department of Surgical Sciences, University of Oxford, UK

Ally Bradley

Nuffield Department of Surgical Sciences, University of Oxford, UK

Andrew Butler

University of Cambridge Department of Surgery, Addenbrooke’s Hospital, Cambridge, UK

Virginia Chiocchia

Surgical Intervention Trials Unit, Nuffield Department of Surgical Sciences, University of Oxford, UK

Susan Dutton

Centre for Statistics in Medicine, University of Oxford, UK

Juan Carlos García-Valdecasas

Hospital Clinic, University of Barcelona, Spain

Charles Imber

Department of Hepatopancreatobiliary and Liver Transplant Surgery, Royal Free Hospital, London, UK

Wayel Jassem

Institute of Liver Studies, King's College Hospital, London, UK

Simon Knight

Nuffield Department of Surgical Sciences, University of Oxford, UK