Liver TransplantationDHOPEPROLONGNCT05680246
Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Donor Livers (DHOPEPROLONG)
An observational study of Liver Transplantation, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
End-ischemic dual hypothermic oxygenated machine perfusion (DHOPE) of human donor livers mitigates ischemia-reperfusion injury, resulting in a reduction of post-reperfusion syndrome, early allograft dysfunction and biliary complications, when compared with static cold storage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- DHOPE-PRO
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2023to Dec 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
Study population: Adult liver transplant recipients
Who may be able to join
- Adult patients (>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic DHOPE for >4 hours
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713GZ
Vincent E de Meijer, MD, PhD, +31503616161, v.e.de.meijer@umcg.nl
Vincent E de Meijer, MD, PhD
About this study
Official title: Prospective Observational Study to Investigate Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Human Donor Livers (DHOPEPROLONG)
End-ischemic dual hypothermic oxygenated machine perfusion (DHOPE) of human donor livers mitigates ischemia-reperfusion injury, resulting in a reduction of post-reperfusion syndrome, early allograft dysfunction and biliary complications, when compared with static cold storage. End-ischemic DHOPE can be used to prolong donor liver preservation time for up to 24 hours. According to IDEAL-D (Idea, Development, Exploration, Assessment, Long term study-Framework for Devices), scientific evidence for prolonged DHOPE has currently reached stage 3. Assessment of long-term outcomes after prolonged DHOPE preservation based on real-world data (i.e., IDEAL-D stage 4) is currently still lacking.
Read the detailed description
The aim of this study is to assess long-term outcomes after transplantation of donor livers preserved by prolonged hypothermic oxygenated machine perfusion (DHOPE-PRO).
- Conditions
- Liver Transplantation
- Being tested
- DHOPE-PRO
- Keywords
- machine preservation, machine perfusion, donor organ preservation, hypothermic oxygenated machine perfusion, donor liver machine perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHOPE-PRODevice
Prolonged DHOPE preservation >4 hours
| Study group | Role | What they receive |
|---|---|---|
| DHOPE-PRO | Outcomes of recipients who underwent liver transplantation of donor organs that were perfused with prolonged (>4 hours) DHOPE. Receives: Device: DHOPE-PRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death-censored graft survival
Death-censored graft survival, assessed by survival analysis methods.
Measured: Up to 5-years
Secondary outcomes (11)
Overall graft survival
Overall graft survival, assessed by survival analysis methods.
Measured: Up to 5-years
overall patient survival
overall patient survival, assessed by survival analysis methods.
Measured: Up to 5-years
arterial and biliary complication-free survival (ABCFS)
arterial and biliary complication-free survival (ABCFS), assessed by survival analysis methods.
Measured: Up to 5-years
incidence of biliary complications
incidence of biliary complications
Measured: Up to 5-years
incidence of vascular complications
incidence of vascular complications
Measured: Up to 5-years
incidence of acute cellular rejection
incidence of acute cellular rejection
Measured: Up to 5-years
incidence of chronic rejection
incidence of chronic rejection
Measured: Up to 5-years
incidence of re-transplantation
incidence of re-transplantation
Measured: Up to 5-years
incidence of recurrence of primary disease
incidence of recurrence of primary disease (including recurrence of malignancies)
Measured: Up to 5-years
incidence of new-onset chronic kidney disease
incidence of new-onset chronic kidney disease
Measured: Up to 5-years
incidence of new-onset diabetes after transplantation
incidence of new-onset diabetes after transplantation
Measured: Up to 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Jan 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent E de Meijer, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680246
- Sponsor's protocol ID
- UMCG_DHOPE-PRO-LONG_2023/01
- Acronym
- DHOPEPROLONG
- Status last verified
- May 2024
- First submitted
- 25 Dec 2022
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be shared upon reasonable request, only with appreciation of the national and local institute's privacy regulations
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Investigate Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Human Donor Livers (DHOPEPROLONG)
- ClinicalTrials.gov ID
- NCT05680246
- Acronym / sponsor ID
- DHOPEPROLONG / UMCG_DHOPE-PRO-LONG_2023/01
- Conditions
- Liver Transplantation
- Keywords
- machine preservation, machine perfusion, donor organ preservation, hypothermic oxygenated machine perfusion, donor liver machine perfusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 11 Jan 2023 (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.
End-ischemic dual hypothermic oxygenated machine perfusion (DHOPE) of human donor livers mitigates ischemia-reperfusion injury, resulting in a reduction of post-reperfusion syndrome, early allograft dysfunction and biliary complications, when compared with static cold storage. End-ischemic DHOPE can be used to prolong donor liver preservation time for up to 24 hours. According to IDEAL-D (Idea, Development, Exploration, Assessment, Long term study-Framework for Devices), scientific evidence for prolonged DHOPE has currently reached stage 3. Assessment of long-term outcomes after prolonged DHOPE preservation based on real-world data (i.e., IDEAL-D stage 4) is currently still lacking.
Detailed description
The aim of this study is to assess long-term outcomes after transplantation of donor livers preserved by prolonged hypothermic oxygenated machine perfusion (DHOPE-PRO).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DHOPE-PRO | – | Device: DHOPE-PROOutcomes of recipients who underwent liver transplantation of donor organs that were perfused with prolonged (>4 hours) DHOPE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult liver transplant recipients
Key inclusion criteria (1 listed)
- Adult patients (>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic DHOPE for >4 hours
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| DHOPE-PROProlonged DHOPE preservation >4 hours | Device | DHOPE-PRO |
Primary outcome
Death-censored graft survival
Time frame: Up to 5-years
Death-censored graft survival, assessed by survival analysis methods.
11 secondary outcomes
Overall graft survival
Time frame: Up to 5-years
overall patient survival
Time frame: Up to 5-years
arterial and biliary complication-free survival (ABCFS)
Time frame: Up to 5-years
incidence of biliary complications
Time frame: Up to 5-years
incidence of vascular complications
Time frame: Up to 5-years
incidence of acute cellular rejection
Time frame: Up to 5-years
incidence of chronic rejection
Time frame: Up to 5-years
incidence of re-transplantation
Time frame: Up to 5-years
incidence of recurrence of primary disease
Time frame: Up to 5-years
incidence of new-onset chronic kidney disease
Time frame: Up to 5-years
incidence of new-onset diabetes after transplantation
Time frame: Up to 5-years
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 21 May 2024.
- Individual participant dataSharing planned: Undecided. IPD may be shared upon reasonable request, only with appreciation of the national and local institute's privacy regulations
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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.
Vincent E de Meijer, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by University Medical Center Groningen at 1 site in Netherlands.
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 1 inclusion and 1 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 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 Vincent E de Meijer, MD, PhD (+31503616161, v.e.de.meijer@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death-censored graft survival (time frame: Up to 5-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2024.