Assessing long-term outcomes of donor livers preserved with machine perfusion
Prospective Observational Study to Investigate Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Human Donor Livers (DHOPEPROLONG)
This study looks at whether using a special machine to keep donor livers healthy for longer before transplant can help people have better long-term outcomes after their liver surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT05680246 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term outcomes of liver transplants using donor livers preserved through prolonged dual hypothermic oxygenated machine perfusion (DHOPE). The study focuses on real-world data to assess the effectiveness of DHOPE in reducing complications associated with liver transplantation, such as ischemia-reperfusion injury and early allograft dysfunction. By analyzing outcomes from adult patients who received liver transplants after DHOPE preservation for more than four hours, the study seeks to fill the gap in existing evidence regarding the long-term benefits of this preservation method.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients over 18 years old who have undergone liver transplantation using donor livers preserved with DHOPE for more than four hours.
Not a fit: Patients who received liver transplants from donors preserved using methods other than DHOPE may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved long-term outcomes for liver transplant recipients by minimizing complications associated with organ preservation.
How similar studies have performed: While the approach of using DHOPE for liver preservation is advancing, this specific long-term outcome assessment is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (\>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic DHOPE for \>4 hours Exclusion Criteria: * None
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Vincent E de Meijer, MD, PhD — University Medical Center Groningen
- Study coordinator: Vincent E de Meijer, MD, PhD
- Email: v.e.de.meijer@umcg.nl
- Phone: +31503616161
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.