To study the safety and efficacy of prolonged (>2 hours) end-ischemic DHOPE, by assessing the occurrence of (serious) adverse events during machine perfusion and within 30 days after liver transplantation.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is a composite of the occurrence of all (serious)
adverse events during regular and prolonged DHOPE machine preservation, and
within 30 days after liver transplantation.
Secondary outcome
To study the safety and efficacy of extended end-ischemic DHOPE of donor
livers, by assessing the following parameters:
Postoperative complications according to the Clavien-Dindo classification as
well as the comprehensive complication index (CCI) within 30 days after LT;
Incidence of acute kindey injury within 30 days after liver transplantation
Incidence of biliary complications within 12 months after LT;
Graft and patient survival 12 months after LT
Background summary
Dual hypothermic oxygenated machine perfusion (DHOPE) reconditions the liver
graft by inducing a hypometabolic state whilst restoring mitochondrial function
through the delivery of oxygen. End-ischemia dynamic preservation of the donor
liver by DHOPE for 1-2 hours prior to transplantation is sufficient to mitigate
organ damage and fully restore cellular energy stores. Clinical studies have
shown that short-term end-ischemic DHOPE reduces (biliary) complications and
improves graft survival after liver transplantation. In addition to graft
reconditioning, DHOPE may also have the potential to prolong preservation time
to facilitate logistics for allocation and transplantation of the donor liver.
Liver transplantation could be scheduled the next morning instead of during the
night, since the latter has been associated with a greater risk of morbidity
and mortality. Both the transplant team and the recipient commence the surgery
well-rested, rather than in the middle of the night. We have recently shown
that prolonged DHOPE enabled successful preservation of porcine and discarded
human livers for up to 24 hours. If confirmed to the clinical setting,
prolonged DHOPE could be used globally to facilitate transplantation logistics.
Study objective
To study the safety and efficacy of prolonged (>2 hours) end-ischemic DHOPE, by
assessing the occurrence of (serious) adverse events during machine perfusion
and within 30 days after liver transplantation.
Study design
A prospective, non-randomized, dual-arm, single-center safety and efficacy
trial involving 24 donor livers and recipients. The end-time of donor
hepatectomy (independently determined by the off-site donation professional)
will determine whether the graft will be assigned to the intervention (4pm-4am)
or to the control arm (4:01am-3:59pm). In each group, 6 grafts obtained from
donors after circulatory death and 12 grafts from donors after brain death will
be included (stratification).
Intervention
Prolonged end-ischemic DHOPE (8-12ºC) using a Liver Assist device until
implantation the following morning (>2 hours).
Study burden and risks
A potential risk is that the components of the disposable set deteriorate after
6 hours machine perfusion. Hence, insufficient oxygenation of the solution,
leakage of perfusion solution, or air bubble formation could occur. Ultimately,
this could lead to discard of the organ. However, these risks are very unlikely
as previous tests carried out by Organ Assist have shown none of the above
occurred during 36 hours cold machine perfusion.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
Recipient:
Adult patients (>=18 years old)
Primary liver transplantation or retransplantation;
Given informed consent
Donor:
With a body weight >=40 kg;
Donation after brain death
Exclusion criteria
Recipient:
Simultaneous participation in another clinical trial that might possibly
influence this trial;
Combined organ transplantation;
Mental conditions rendering the subject incapable to understand the nature,
scope, and consequences of the trial;
High-urgency status;
Laboratory MELD score >30;
Test positive for HIV
Donor:
DCD donor
Donor with untreated HIV, HVB, HCV
Split or partial grafts;
Domino donor livers;
Living donor livers;
Estimated graft steatosis >30%
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72559.042.20 |