Assessing liver graft viability during organ procurement
Metabolomics Based Prediction Model for Liver Graft Viability During Normothermic Regional Perfusion in Donation After Circulatory Death
This study is testing a new way to check if liver donations from deceased donors are healthy enough to use, in hopes of helping more people get successful liver transplants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 66 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 4 sites (Clichy and 3 other locations) |
| Trial ID | NCT05361044 on ClinicalTrials.gov |
What this trial studies
This study focuses on improving liver transplantation outcomes by evaluating the viability of liver grafts obtained from donation after circulatory death (DCD) using normothermic regional perfusion (NRP). The approach aims to expand the selection criteria for liver grafts, reducing the number of viable organs that are discarded due to strict quality assessments. By including adult recipients on the waiting list for liver transplantation, the study seeks to enhance post-transplant survival rates and overall patient outcomes. The research is conducted across multiple transplant centers in France, utilizing blood samples from donors during the procurement process.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18 to 65 who are on the waiting list for liver transplantation and meet specific health criteria.
Not a fit: Patients with severe comorbidities or those who are too sick to cope with post-reperfusion syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase the number of viable liver grafts available for transplantation, improving patient outcomes.
How similar studies have performed: Previous studies using normothermic regional perfusion in liver transplantation have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All cDCD liver grafts allocated to one of the study centers undergoing NRP and where procurement of any abdominal organ is initiated * Procurement performed by one of the four transplant teams * non opposition by the donor or his family to organ donation * non opposition by the recipient to participate in the study * All Adult recipients on the waiting list for liver transplantation elligible for a liver procured after circulatory death according to the Agence de la Biomedecine. * Recipient, aged at least 18 years and less than 66 years, * Awaiting a first transplantation, * Recipients considered not too sick to cope with post-reperfusion syndrome not ventilated, no inotropic agents ...) * No major surgical history and no portal vein thrombosis; To minimize cold and recipient ischemic time (anastomotic time), patients where the recipient hepatectomy was predicted to be difficult were excluded * With a MELD score ≤ 25 * Patient has been duly informed and has consented. Although the results of transplantations after DCD have very clearly improved over the years, clear information for the recipient and the provision of informed consent both remain essential. This means making clear to the patient the risk of primary nonfunction as well as of ischemic cholangiopathy and early arterial thrombosis. Exclusion Criteria: -- cDCD procurement where NRP fails or is not initiated due to technical reasons - Graft reallocation after procurement to a transplant team not included in the study
Where this trial is running
Clichy and 3 other locations
- Department of HPB surgery and liver transplantation — Clichy, France (Not_yet_recruiting)
- Department of general surgery and liver transplantation, Croix-Rousse University Hospital 103 Boulevard de la Croix Rousse — Lyon, France (Recruiting)
- Department of HPB surgery and liver transplantation — Paris, France (Not_yet_recruiting)
- Department of HPB and Digestive Surgery — Rennes, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Guillaume Rossignol, MD
- Email: Guillaume.rossignol@chu-lyon.fr
- Phone: 0426109439
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.