Liver TransplantationExTraNCT06874296
Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time
A study testing Quality Assessment with Normothermic Machine Perfusion (NMP) in people with Liver Transplantation and Liver Diseases, run by Charite University, Berlin, Germany at 10 sites in Germany.
Trial summary
The goal of this study is to find out if quality assessment by normothermic machine perfusion can be used to safely increase the number of usable donor livers, helping more people get transplants faster and with better results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Liver Diseases, Surgery
- What is being tested?
- Quality Assessment with Normothermic Machine Perfusion (NMP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 10 sitesGermany
- Study dates
- 2 Jun 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to consent
- ≥ 18 years old
- Listed in status "transplantable" by the transplant conference of the study centre for liver transplantation, according to the guidelines of the German Medical Association valid at the time of inclusion
- ReMELD-Na-Score ≤ 21 (equivalent to MELD ≤25), not eligible for [non]standard exceptions
- Medically suitable and informed for transplantation with an organ that fulfils extended donor criteria (Eurotransplant ECD criteria)
- Patient information and written consent to participate in the Extra trial
- No participation in another interventional study during participation
Who cannot join
- Listed for retransplantation
- High-Urgency Listing
- Listed for combined organ transplantation
- Pregnancy
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Germany10 sites, 10 recruiting
- Recruiting
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
Nils Laurenz, +49 241 80 89500, nlaurenz@ukaachen.de
- Recruiting
Department of Surgery Campus Charité Mitte | Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 13353
Nathanael Raschzok, MD, +49 30 450 552001, extra-trial@charite.de
Simon Moosburner, MD
- Recruiting
University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127
Steffen Manekeller, MD, +49 228 287 15215, steffen.manekeller@ukbonn.de
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20251
Jacqueline Jahnke-Triankowski, +49 40 7410 52401, j.jahnke-triankowski@uke.de
- Recruiting
Department of General, Visceral and Transplant Surgery, Hannover Medical School
Hanover
Philipp Felgendreff, MD, +49 0511 532-6534/6527, felgendreff.philipp@mh-hannover.de
- Recruiting
Department of General, Visceral and Transplantation Surgery, LMU University Hospital, LMU Munich
München
Michael Eder, +49 089 4400-76573, kcs@med.uni-muenchen.de
- Recruiting
University Hospital Muenster
Münster, North Rhine-Westphalia, 49149
Kerstin Kemmann, +49 251 83 56361, kerstin.kemmann@ukmuenster.de
- Recruiting
Department of Surgery, University Hospital Regensburg
Regensburg
Stefan Brunner, +49 0941 944-6809, Stefan.Brunner@ukr.de
- Recruiting
Eberhard Karls University of Tübingen, Department of General Visceral and Transplant Surgery
Tübingen
Lisa Vogt, +49 07071 29-61681, Lisa.Vogt@med.uni-tuebingen.de
- Recruiting
Department of General, Visceral, Transplantation, Vascular, and Pediatric Surgery, University Hospital Wurzburg
Würzburg
Johann Lock, +49 931 201-0, Lock_J@ukw.de
About this study
Official title: Pilot, Open, Prospective, Randomized, Multicenter Trial On Quality Assessment Of Declined Liver Grafts By Normothermic Ex Vivo Machine Perfusion For Decreasing Time To Transplantation
The goal of this study is to find out if quality assessment by normothermic machine perfusion can be used to safely increase the number of usable donor livers, helping more people get transplants faster and with better results. This process keeps a donated liver working outside the body before transplantation, allowing surgeons to assess whether livers previously considered unsuitable can still be used.
The main questions this study aims to answer are:
Read more
- Does this method help patients get a transplant sooner?
- Can this method make more livers available for transplant?
- Does it improve survival and health after transplant?
Participants in this study must be on the waiting list for a liver transplant with a ReMELD-Na-Score of 21 or less (equivalent to MELD ≤25) and must not qualify for certain special exceptions. Participants will be randomly placed into one of two groups:
- Experimental group: In addition to regular organ offers, these participants may receive a liver that was initially not considered for transplantation but meets quality standards after at least four hours of machine perfusion.
- Control group: These participants will receive a liver through the usual transplant process.
The main measure of success is how quickly participants receive a transplant. Researchers will also look at other important factors, such as survival rates, quality of life, hospital stay, and complications after transplant.
This study may help improve liver transplantation by making better use of available donor livers, reducing waiting times, and improving patient outcomes.
Read the detailed description
Liver transplantation is the treatment of choice for patients with advanced liver cirrhosis, hepatocellular carcinoma within the Milan criteria, and severe metabolic or autoimmune liver diseases. However, organ shortage remains a significant issue, particularly in Germany, where only 58% of patients on the waiting list received a transplant in 2022. Patients with MELD ≤25, who are ineligible for [Non]-Standard Exception criteria, face particularly long waiting times and lower transplant rates.
Despite the shortage, approximately 24% of all liver grafts in Germany are declined due to donor age, macrosteatosis, or prolonged cold ischemia. Emerging technologies, such as NMP, allow for objective graft quality assessment before transplantation. Several non-randomized studies in the UK, Netherlands, Australia, and the USA have demonstrated the potential of NMP to increase organ utilization. The ExTra trial is the first randomized controlled study to investigate whether declined liver grafts, following NMP-based quality assessment, can safely and effectively reduce the waiting time for patients with ReMELD-Na-Score ≤ 21(equivalent to MELD ≤25).
- Conditions
- Liver Transplantation, Liver Diseases, Surgery
- Being tested
- Quality Assessment with Normothermic Machine Perfusion (NMP)
- Keywords
- Liver Transplantation, Extended Criteria Donors, Normothermic Machine Perfusion, Discarded Liver Grafts
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Assessment with Normothermic Machine Perfusion (NMP)Device
Quality assessment using NMP in the experimental arm is performed according to previously published viability criteria for initially declined liver grafts, which are mandatory for all participating study centers, with minor device-specific modifications. These criteria are based on the Birmingham criteria used in the VITTAL trial for viability assessment of DBD and DCD grafts with the OrganOx Metra device and are comparable to the Groningen criteria used with the LiverAssist and PerLife device, with the exception of biliary viability.
These criteria are: Lactate clearance < 2.5 mmol/L, And two or more of the following: Evidence of bile production, maintenance of a perfusate pH >7.30 (without correction for at least one hour), glucose metabolism (falling perfusate glucose value with consistent downward trend), maintenance of stable arterial and portal venous flows (OrganOx Metra: 150 and 500 mL/min respectively), homogeneous perfusion with soft consistency of the parenchyma.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Patient will be listed for liver transplantation through standard allocation only. |
| ExTra Option | Experimental | Patients will receive the option to receive a graft that was declined by all German Transplant Centers but meets predefined quality criteria during at least 4 hours of normothermic machine perfusion (ExTra-LT) or a liver via regular allocation - whichever occurs first.
Declined liver grafts will be allocated based on Eurotransplant's first-come-first-serve principle, with consideration for transport logistics and recipient eligibility. Only grafts meeting the following criteria will be considered: Macrovesicular steatosis <60%, fibrosis grade ≤F3, no histopathologic evidence of cirrhosis, graft weight between 1-2.5 kg, no previous machine perfusion preservation. Receives: Device: Quality Assessment with Normothermic Machine Perfusion (NMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-Transplant
Measured: From date of randomization to liver transplantation (up to 12 months after date of randomization)
Secondary outcomes (8)
Death
Patient death during the 12-month intervention period, regardless of liver transplantation or not.
Measured: From date of randomization to death (up to 12 months after date of randomization)
Disease Progression
Change of ReMELD-Na-Score above 21 while listed as "transplantable" on the waitlist. Occurence of new contraindication for liver transplantation
Measured: From date of randomization to event (up to 12 months after date of randomization)
Proportion of Patients Recovered on the Waitlist
Proportion of patients with change in overall health that no liver transplantation is further required in relation to all patients on the waitlist in the trial.
Measured: From date of randomization to event (up to 12 months after date of randomization)
Number of patients listed for transplantation after 12 months
Number of patients listed for transplantation after 12 months.
Measured: 12 months after randomization
Overall patient survival
Overall patient survival in the study.
Measured: From date of randomization to death (up to 24 months after date of randomization)
Patient-reported Quality of Life
Patient-reported Quality of Life measured in the EuroQOL EQ5DL. Two aspects will be reported: The EuroQOL visual analog scale (EQ VAS) on a scale from 0-100 points and the proportion of responses by level of severity for the five EQ-5D-5L dimensions (each reported on a five level scale).
Measured: up to 24 months
Graft utilization rate
Proportion of used livers of all organs offered to patients on the waiting list
Measured: up to 12 months
Inpatient Costs for Liver Transplantation
Analysis of liver transplantation-associated costs. This will be total costs, earnings and profit measured in Euros (EUR) for the primary inpatient stay of liver transplantation.
Measured: First 90 days after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start2 Jun 2025
- Primary completion31 May 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The treatment in the intervention arm will be available for patient for 12 months after randomization. Patients who have not yet received a graft after 12 months and are therefore still on the waiting list are administratively censored.
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Nathanael Raschzok, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874296
- Sponsor's protocol ID
- 20024292
- Other IDs
- 543051616
- Acronym
- ExTra
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared due to data protection regulations and ethical considerations. Given the sensitive nature of the data, strict confidentiality measures must be maintained to protect participants' privacy. Compliance with GDPR and institutional policies prevents the disclosure of personally identifiable information, ensuring that data handling aligns with legal and ethical standards.
Publications
Moosburner S MHBA, Gassner JMGV, Sauer IM, Mandac M, Modest DP, Zocholl D, Stegherr R, Patel MS, Wendon J, Roderburg C, Selzner M, Pascher A, Fehrenbach U, Pratschke J, Raschzok N. Open, prospective, randomised, multicentre trial on quality assessment of declined liver grafts by normothermic ex situ machine perfusion for decreasing time to transplantation (ExTra trial): a study protocol. BMJ Open. 2026 Aug 13;16(8):e114833. doi: 10.1136/bmjopen-2025-114833.
PubMed 42595371
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Open, Prospective, Randomized, Multicenter Trial On Quality Assessment Of Declined Liver Grafts By Normothermic Ex Vivo Machine Perfusion For Decreasing Time To Transplantation
- ClinicalTrials.gov ID
- NCT06874296
- Acronym / sponsor ID
- ExTra / 20024292
- Conditions
- Liver Transplantation, Liver Diseases, Surgery
- Keywords
- Liver Transplantation, Extended Criteria Donors, Normothermic Machine Perfusion, Discarded Liver Grafts
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to find out if quality assessment by normothermic machine perfusion can be used to safely increase the number of usable donor livers, helping more people get transplants faster and with better results. This process keeps a donated liver working outside the body before transplantation, allowing surgeons to assess whether livers previously considered unsuitable can still be used.
The main questions this study aims to answer are:
- Does this method help patients get a transplant sooner?
- Can this method make more livers available for transplant?
- Does it improve survival and health after transplant?
Participants in this study must be on the waiting list for a liver transplant with a ReMELD-Na-Score of 21 or less (equivalent to MELD ≤25) and must not qualify for certain special exceptions. Participants will be randomly placed into one of two groups:
- Experimental group: In addition to regular organ offers, these participants may receive a liver that was initially not considered for transplantation but meets quality standards after at least four hours of machine perfusion.
- Control group: These participants will receive a liver through the usual transplant process.
The main measure of success is how quickly participants receive a transplant. Researchers will also look at other important factors, such as survival rates, quality of life, hospital stay, and complications after transplant.
This study may help improve liver transplantation by making better use of available donor livers, reducing waiting times, and improving patient outcomes.
Detailed description
Liver transplantation is the treatment of choice for patients with advanced liver cirrhosis, hepatocellular carcinoma within the Milan criteria, and severe metabolic or autoimmune liver diseases. However, organ shortage remains a significant issue, particularly in Germany, where only 58% of patients on the waiting list received a transplant in 2022. Patients with MELD ≤25, who are ineligible for [Non]-Standard Exception criteria, face particularly long waiting times and lower transplant rates.
Despite the shortage, approximately 24% of all liver grafts in Germany are declined due to donor age, macrosteatosis, or prolonged cold ischemia. Emerging technologies, such as NMP, allow for objective graft quality assessment before transplantation. Several non-randomized studies in the UK, Netherlands, Australia, and the USA have demonstrated the potential of NMP to increase organ utilization. The ExTra trial is the first randomized controlled study to investigate whether declined liver grafts, following NMP-based quality assessment, can safely and effectively reduce the waiting time for patients with ReMELD-Na-Score ≤ 21(equivalent to MELD ≤25).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The treatment in the intervention arm will be available for patient for 12 months after randomization. Patients who have not yet received a graft after 12 months and are therefore still on the waiting list are administratively censored.
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Patient will be listed for liver transplantation through standard allocation only. |
| ExTra Option | Experimental | Device: Quality Assessment with Normothermic Machine Perfusion (NMP)Patients will receive the option to receive a graft that was declined by all German Transplant Centers but meets predefined quality criteria during at least 4 hours of normothermic machine perfusion (ExTra-LT) or a liver via regular allocation - whichever occurs first. Declined liver grafts will be allocated based on Eurotransplant's first-come-first-serve principle, with consideration for transport logistics and recipient eligibility. Only grafts meeting the following criteria will be considered: Macrovesicular steatosis <60%, fibrosis grade ≤F3, no histopathologic evidence of cirrhosis, graft weight between 1-2.5 kg, no previous machine perfusion preservation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to consent
- ≥ 18 years old
- Listed in status "transplantable" by the transplant conference of the study centre for liver transplantation, according to the guidelines of the German Medical Association valid at the time of inclusion
- ReMELD-Na-Score ≤ 21 (equivalent to MELD ≤25), not eligible for [non]standard exceptions
- Medically suitable and informed for transplantation with an organ that fulfils extended donor criteria (Eurotransplant ECD criteria)
Key exclusion criteria (4 listed)
- Listed for retransplantation
- High-Urgency Listing
- Listed for combined organ transplantation
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality Assessment with Normothermic Machine Perfusion (NMP)Quality assessment using NMP in the experimental arm is performed according to previously published viability criteria for initially declined liver grafts, which are mandatory for all participating study centers, with minor device-specific modifications. These criteria are based on the Birmingham criteria used in the VITTAL trial for viability assessment of DBD and DCD grafts with the OrganOx Metra device and are comparable to the Groningen criteria used with the LiverAssist and PerLife device, with the exception of biliary viability. These criteria are: Lactate clearance < 2.5 mmol/L, And two or more of the following: Evidence of bile production, maintenance of a perfusate pH >7.30 (without correction for at least one hour), glucose metabolism (falling perfusate glucose value with consistent downward trend), maintenance of stable arterial and portal venous flows (OrganOx Metra: 150 and 500 mL/min respectively), homogeneous perfusion with soft consistency of the parenchyma. | Device | ExTra Option |
Primary outcome
Time-to-Transplant
Time frame: From date of randomization to liver transplantation (up to 12 months after date of randomization)
8 secondary outcomes
Death
Time frame: From date of randomization to death (up to 12 months after date of randomization)
Disease Progression
Time frame: From date of randomization to event (up to 12 months after date of randomization)
Proportion of Patients Recovered on the Waitlist
Time frame: From date of randomization to event (up to 12 months after date of randomization)
Number of patients listed for transplantation after 12 months
Time frame: 12 months after randomization
Overall patient survival
Time frame: From date of randomization to death (up to 24 months after date of randomization)
Patient-reported Quality of Life
Time frame: up to 24 months
Graft utilization rate
Time frame: up to 12 months
Inpatient Costs for Liver Transplantation
Time frame: First 90 days after liver transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Derived from this study: PubMed 42595371Moosburner S MHBA, Gassner JMGV, Sauer IM, Mandac M, Modest DP, Zocholl D, Stegherr R, Patel MS, Wendon J, Roderburg C, Selzner M, Pascher A, Fehrenbach U, Pratschke J, Raschzok N. Open, prospective, randomised, multicentre trial on quality assessment of declined liver grafts by normothermic ex situ machine perfusion for decreasing time to transplantation (ExTra trial): a study protocol. BMJ Open. 2026 Aug 13;16(8):e114833. doi: 10.1136/bmjopen-2025-114833.
- Official Trial HomepageLink provided by the sponsor.
- Funding InformationLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared due to data protection regulations and ethical considerations. Given the sensitive nature of the data, strict confidentiality measures must be maintained to protect participants' privacy. Compliance with GDPR and institutional policies prevents the disclosure of personally identifiable information, ensuring that data handling aligns with legal and ethical standards.
Related trials for Liver Transplantation
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality Assessment with Normothermic Machine Perfusion (NMP) in people with Liver Transplantation and Liver Diseases, run by Charite University, Berlin, Germany at 10 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathanael Raschzok, MD (+49 30 450 552 001, nathanael.raschzok@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-Transplant (time frame: From date of randomization to liver transplantation (up to 12 months after date of randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06874296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.