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Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time

Study acronym: ExTra
StatusRecruiting
PhaseNot applicable
Started2025-06-02
View on ClinicalTrials.gov ↗

Amendment history

2026-04-14
minor
Study Status, Contacts/Locations v7
Study sites9→10
2026-02-01
minor
Study Status, Contacts/Locations v6
Study sites5→9
2025-11-28
minor
Study Status, Arms and Interventions, Contacts/Locations, References v5
Study sites1→5
2025-09-01
notable
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-06-01→confirmed 2025-06-02
Study sitesdetails revised at 1 of 1 site
2025-05-09
minor
Study Status, Contacts/Locations v3
Study sites0→1
Show 2 earlier versions
2025-04-14
minor
Study Status, Oversight, Study Description v2
Re-verified, no change to tracked fields
2025-04-03
minor
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility v1
Primary completion date2029-03-31→2029-05-31
Start date2025-04-01→2025-06-01
Eligibility criteria+53 characters
Inclusion Criteria: Able to consent ≥ 18 years old Listed in status "transplantable" by the tran [...] e German Medical Association valid at the time of inclusion ReMELD-Na-Score ≤ 21 (equivalent to MELD ≤25), not eligible for [non]standard exceptions Medically suitab [...]
Secondary endpointsdetails revised at 1 of 8 entries
Study description+36 characters
[...] y and effectively reduce the waiting time for patients with ReMELD-Na-Score ≤ 21(equivalent to MELD ≤25).
Study titlerevised
Assessing Declined Liver Grafts withWith Normothermic Machine Perfusion to Reduce Transplant Waiting Time
2025-03-07
minor
Original filing
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.
Trial Details
NCT Number NCT06874296
Lead Sponsor Charite University, Berlin, Germany
Collaborators: German Research Foundation
Conditions Liver Transplantation, Liver Diseases, Surgery
Enrollment 186 participants
Start Date 2025-06-02
Primary Completion 2029-05-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-15