Liver Disease (Alcoholic or Not)INSPIRE-NLNCT07899853
In-situ vs Ex-situ Liver Preservation
A study testing In-situ perfusion: aNRP and Ex-situ perfusion: DHOPE/DHOPE-COR-NMP in people with Liver Disease (Alcoholic or Not) and Transplantation, run by Leiden University Medical Center at 3 sites in Netherlands.
Trial summary
The goal of this Randomized Controlled Trial is to learn what machine preservation method is most clinically effective for liver transplantation (LTx) after donation after circulatory death (DCD). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Liver Disease (Alcoholic or Not), Transplantation
- What is being tested?
- In-situ perfusion: aNRP and Ex-situ perfusion: DHOPE/DHOPE-COR-NMP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 752 participants
- Where
- 3 sitesNetherlands
- Study dates
- 4 Nov 2026to 1 Oct 2032
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All DCD donor livers (donor=>16 years) accepted for transplantation in the Netherlands
Who cannot join
- HU recipients
- Logistical or technical constraints for machine perfusion
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Recruiting
University Medical Center Groningen
Groningen
Vincent E de Meijer, MD PhD, +31-645955548, v.e.de.meijer@umcg.nl
Wouke N Kuiper, Msc, +31-655257880, w.n.kuiper@umcg.nl
- Not yet recruiting
Leiden University Medical Center
Leiden
Volkert A. Huurman, MD PhD, +31-624801027, v.a.l.huurman@lumc.nl
Niki Lupgens, Msc, n.l.lupgens@lumc.nl
- Recruiting
Erasmus Medical Center
Rotterdam, 3015 GD
Jeroen de Jonge, MD PhD, +31-643904182, j.dejonge.1@erasmusmc.nl
Sophie Ciere, Bsc, +31-640191073, s.ciere@erasmusmc.nl
About this study
Official title: IN Situ Versus ex Situ Organ PreservatIon: a Randomized Evaluation in the Netherlands (INSPIRE-NL)
The goal of this Randomized Controlled Trial is to learn what machine preservation method is most clinically effective for liver transplantation (LTx) after donation after circulatory death (DCD). The main questions it aims to answer are:
- What perfusion method has the lowest death censored biliary complication rate at 1-year post LT?
- Are there differences in the Core Outcome Set of liver transplantation outcomes?
- Are there any differences in utilization outcomes?
- Are there any differences in cost effectiveness?
- Are there any differences in patient quality of life?
- Are there any differences in resource utilization?
Read more
Researchers will compare preservation using in-situ abdominal normothermic regional perfusion (aNRP) to (dual) hypothermic oxygenated perfusion (DHOPE) or DHOPE followed by controlled oxygenated rewarming and normothermic machine perfusion (DHOPE-COR-NMP).
Nothing will change from clinical practice for the liver recipients.
Read the detailed description
RELEVANCE Around 15% of waiting-list patients for liver transplantation are removed prematurely due to death or clinical deterioration. To reduce donor liver shortage, lower-quality livers are increasingly used, including those from donation after circulatory death (DCD), though these carry a higher risk of complications. Several machine perfusion techniques have been developed to recondition and/or assess donor livers: 'in situ' abdominal Normothermic Regional Perfusion (aNRP), and 'ex-situ' Dual Hypothermic Oxygenated Perfusion (DHOPE), in some cases followed by Controlled Oxygenated Rewarming (COR) and Normothermic Machine perfusion (NMP). All these techniques are reimbursed as proven effective treatment in the Netherlands. It remains unclear which strategy is most effective and cost-efficient for DCD livers. A direct comparison is needed to answer this question and decide on a future standard of care.
RESEARCH QUESTION Which machine perfusion technique is most clinically effective and cost-effective for liver transplantation after DCD?
HYPOTHESIS In situ preservation using aNRP reduces the one year incidence of total biliary complications when compared to ex situ preservation with DHOPE (±COR-NMP), with potential cost advantages.
INTERVENTION In situ perfusion (aNRP), restores oxygenated circulation to abdominal organs shortly after donor cardiac arrest to protect organs and allow functional assessment. In standard risk (SCD)-DCD livers, perfusion is performed for one hour without viability assessment. If (re)classified as high risk (extended criteria or ECD)-DCD liver, perfusion continues for two hours, including viability assessment.
COMPARISON The current standard ex-situ perfusion techniques in DCD liver transplantation: DHOPE for standard-risk SCD-DCD livers; or DHOPE-COR-NMP for ECD-DCD livers.
FOLLOW-UP TIME 60 month inclusion time, 12 month follow-up post-transplantation
STUDY DESIGN Multicenter 1:1 randomized controlled trial. DCD livers will be randomized (Castor EDC) after stratification for type (SCD-DCD or ECD-DCD) and transplantation center. Donor characteristics will be obtained from the Eurotransplant Registry, and perfusion parameters recorded prospectively. Recipient data will be extracted from electronic medical records for mandatory Netherlands Organ Transplant Registry (NOTR) registration.
SAMPLE SIZE \& DATA ANALYSIS SCD-DCD 156 liver transplantations per group, total 312. ECD-DCD 102 liver transplantations per group, total 204. Overall: 516 liver transplantations.
Estimated randomizations: 752 total, approximately 236 procedures/randomisations do not result in transplantation due to long agonal phase and viability assessment.
- Conditions
- Liver Disease (Alcoholic or Not), Transplantation
- Being tested
- In-situ perfusion: aNRP, Ex-situ perfusion: DHOPE/DHOPE-COR-NMP
- Keywords
- liver transplantation, machine perfusion, normothermic regional perfusion, DHOPE, DHOPE-COR-NMP, Health technology assessment
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-situ perfusion: aNRPProcedure or surgery
This arm contains of 2 pre-defined strata: SCD-DCD livers: receiving 1 hour of aNRP, ECD-DCD livers: receiving 2 hours of aNRP. Both treatments are standard of care.
Ex-situ perfusion: DHOPE/DHOPE-COR-NMPProcedure or surgery
This arm contains of 2 pre-defined strata: SCD-DCD livers: receiving DHOPE, ECD-DCD livers: receiving DHOPE-COR-NMP. Both treatments are standard of care.
| Study group | Role | What they receive |
|---|---|---|
| DCD donor livers receiving machine preservation using ex-situ DHOPE +/- COR-NMP | Other | This arm contains of 2 pre-defined strata: SCD-DCD livers: receiving DHOPE, ECD-DCD livers: receiving DHOPE-COR-NMP. Both treatments are standard of care. Receives: Procedure: Ex-situ perfusion: DHOPE/DHOPE-COR-NMP |
| DCD donor livers receiving machine preservation using in-situ aNRP | Other | This arm contains of 2 pre-defined strata: SCD-DCD livers: receiving 1 hour of aNRP, ECD-DCD livers: receiving 2 hours of aNRP. Both treatments are standard of care. Receives: Procedure: In-situ perfusion: aNRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
one-year cumulative incidence of biliary complications
Death censored incidence of biliary complications including biliary anastomotic strictures, post-transplant cholangiopathy and biliary leakages, all that necessitate intervention
Measured: 1 year
Secondary outcomes (37)
cost-effectiveness
QALYs derived from EQ-5D-5L questionnaire measured at six time points: waitlist registration, and at six weeks, three, six, twelve and twenty-four months post-transplantation. If aNRP is estimated to lead to higher costs as well as better health outcomes or to lower costs and worse health outcomes, an incremental cost-effectiveness ratio (ICER) will be calculated (costs per QALY gained or savings per QALY lost). If not, one treatment will be considered dominant. As aNRP perfuses multiple organs at once, the overall costs per procedure and subsequent transplantations will be researched.
Measured: 5 year
Post transplant cholangiopathy rate
Narrowing or irregularity of intra- or extra-hepatic donor bile duct excluding the biliary anastomosis leading to clinical symptoms or laboratory derangements in the absence of hepatic artery thrombosis for which an invasive intervention is required.
Measured: 1 year
patient QOL
Health-Related Quality of Life via PROMIS questionnaire: Patient-Reported Outcomes Measurement Information System, that assesses seven core health domains using 4-item short form items plus one pain intensity item (scale 0-10, with 10 worse outcome).
Measured: 2 year
Patient mortality
Recipient death
Measured: 1 year
Graft loss
Failure of the liver allograft requiring either re-transplantation or leading to recipient mortality.
Measured: 1 year
post-transplant overall complications
Also including vascular complications (hepatic artery and portal vein thrombosis)
And complications graded as Clavien Dindo => 3a, and the comprehensive complication index
Measured: 1 year
duration of hospital and ICU stay
In days
Measured: 1 year
Environmental Demand
Environmental Demand: Measured in global hectares (gha). Converts all physical inputs (Greenhouse Gas Emissions: Measured in kg CO₂e, Electricity: Measured in kWh an Consumables \& Waste: Measured in kg of waste and liters (L) of fluids) into the total biophysical land area required to support each distinct protocol.
Measured: 1 year
Liver utilization rate
How many livers are transplanted and still functioning from organ offer to 1 year post transplantation. It takes in account the acceptance rate, discard rate, transplant rate and 1-year survival.
Measured: 1 year
Postoperative intra-abdominal bleeding
Clinically significant bleeding event requiring percutaneous or surgical re-intervention
Measured: During index in-hospital stay, on average 9 days
Presence of post reperfusion syndrome
A drop in mean arterial pression ≥30% from the baseline for at least 1 min and within 5 min from reperfusion
Measured: During transplantation
Need for renal replacement therapy
Any extracorporeal therapy to supplement or replace renal function that was not present before transplant
Measured: During index in-hospital stay, on average 9 days
Intervention rates
e.g. MRCP, ERCP and percutaneous transhepatic cholangiography drainage
Measured: 1 year
Reoperation rate
Number of reoperations
Measured: 1 year
Early Allograft Failure Simplified Estimation Score
EASE = -0.602 + 0.044*(MELD at transplant) + 0.065*(number of PACKED RED BLOOD CELL transfused units during surgery) + 2.567 (if arterial or portal thrombosis during days 1-10) + 0.000534*(AUC ln AST in POD1,2,3,7,10)2 - 0.093*(AUC ln PLT in POD1,3,7,10) - 7.766*(slope ln PLT in POD1,3,7,10) + 0.795*(slope ln billirubin in POD1,3,7,10) - 0.402 (if center volume ≥70 cases per year).
Five EASE risk groups for graft and patient survival were defined as follows: (1) risk group 1: EASE score < -3.43; (2) risk group 2: -3.43 ≤ EASE score ≤ -1.26; (3) risk group 3: -1.25 ≤ EASE score ≤ -0.75; (4) risk group 4: -0.74 ≤ EASE score ≤ -0.01 (5) risk group 5: 0 ≤ EASE score ≤ 5. Risk group 5 is the worse outcome.
Measured: 10 days post operative
Retransplantation rate
Failure of the liver allograft requiring explant and replacement with an alternative liver graft
Measured: 1 year
Primary non function rate
Graft loss, re-transplantation, or patient death within 14 days of initial transplantation not secondary to hepatic artery thrombosis, biliary complication, recurrent disease or acute rejection.
Measured: 14 days
Anastomotic stricture
Localized narrowing of the biliary anastomosis between the donor and recipient bile ducts for which an invasive intervention is required.
Measured: 1 year
Bile leak
Extra-luminal escape of biliary contents that requires invasive intervention (percutaneous or surgical)
Measured: 1 year
Early allograft dysfunction
Enzymatic changes related to slow-resolving recipient liver disease that resolves without treatment should not be graded as a complication.
Enzymatic changes related to an initially impaired graft function leading to more frequent observation (ie, laboratory tests, repeat ultrasound). Officially diagnosed if a patient meets at least one of the following lab conditions: AST or ALT > 2000 IU/L within the first 7 postoperative days, total bilirubin >= 10 mg/dL on postoperative day 7. International normalized ratio (INR) +. 1.6 on postoperative day 7.
Measured: Postoperative day 7
Death censored graft survival
the probability that a transplanted organ is still functioning exactly one year after the procedure, excluding patients who died with a working organ from the failure count
Measured: 1 year
Overall graft survival
the probability that a transplanted organ is still functioning exactly one year after the procedure
Measured: 1 year
Patient survival
all-cause mortality within 365 days post-transplantation
Measured: 1 year
Accumulated team member working hours
For assessing personnel sustainability. Team members include retrieving surgeons, organ perfusionists, organ donation coordinators, organ transplantation coordinators, transplant surgeons, scrub nurses during retrieval and transplantation, anesthesiologists, anesthetics nurse, drivers.
Measured: 1 year
Readmission rate
Number of readmissions
Measured: 1 year
Creatinine values
before LTx, post-LTx days 1-7 and 10, 6 months, 1, 3 and 5 years. Measured in µmol/L.
Measured: 5 years
Sodium values
before LTx, post-LTx days 1-7 and 10, 6 months, 1, 3 and 5 years. Measured in mmol/L.
Measured: 5 years
Alkaline Phosphatase values
In short: ALP. Measured before LTx, post-LTx days 1-7 and 10, 6 months, 1, 3 and 5 years. Measured in U/L.
Measured: 5 years
Alanine Aminotransferase values
In short: ALT. Measured before LTx, post-LTx days 1-7 and 10, 6 months, 1, 3 and 5 years. Measured in U/L.
Measured: 5 years
gamma-Glutamyl Transferase values
In short: GGT. Measured before LTx, post-LTx days 1-7 and 10, 6 months, 1, 3 and 5 years. Measured in U/L.
Measured: 5 years
Bilirubin values
Measured before LTx, post-LTx days 1-7 and 10, 6 months, 1, 3 and 5 years. Measured in µmol/L.
Measured: 5 years
Aspartate Aminotransferase values
In short: AST. Measured before LTx, post-LTx days 1-7 and 10, 6 months, 1, 3 and 5 years. Measured in U/L.
Measured: 5 years
International Normalized Ratio values
In short: INR. Measured before LTx, post-LTx days 1-7 and 10, 6 months, 1, 3 and 5 years.
Measured: 5 years
Thrombocytes values
Measured before LTx, post-LTx days 1-7 and 10, 6 months, 1, 3 and 5 years. Measured /L.
Measured: 5 years
Urea values
Measured before LTx, post-LTx days 1-7 and 10, 6 months, 1, 3 and 5 years. Measured in mmol/L.
Measured: 5 years
eGFR values
Measured before LTx, post-LTx days 1-7 and 10, 6 months, 1, 3 and 5 years. Measured in mL/min/1.73m²
Measured: 5 years
Utilized organs per donor
Number of organs transplanted per donor
Measured: Peri-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start4 Nov 2026 (estimated)
- Primary completion1 Oct 2031 (estimated)
- Study completion1 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Disease (Alcoholic or Not)Studies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 752 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Erasmus Medical Center, University Medical Center Groningen
- Responsible party
- Principal investigator, Volkert Huurman, Leiden University Medical Center
- Investigators
- Volkert A Huurman, MD PhD, Principal investigator, Leiden University Medical Center, Department of SurgeryJeroen de Jonge, MD PhD, Principal investigator, Erasmus Medical CenterVincent E de Meijer, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899853
- Sponsor's protocol ID
- 11380032520009
- Other IDs
- 15807
- Acronym
- INSPIRE-NL
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared. Anonimization of data needs to be addressed to provide sufficient patient and donor privacy according to national law.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IN Situ Versus ex Situ Organ PreservatIon: a Randomized Evaluation in the Netherlands (INSPIRE-NL)
- ClinicalTrials.gov ID
- NCT07899853
- Acronym / sponsor ID
- INSPIRE-NL / 11380032520009
- Conditions
- Liver Disease (Alcoholic or Not), Transplantation
- Keywords
- liver transplantation, machine perfusion, normothermic regional perfusion, DHOPE, DHOPE-COR-NMP, Health technology assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 752 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Erasmus Medical Center, University Medical Center Groningen
- Study start
- 4 Nov 2026 (estimated)
- Primary completion
- 1 Oct 2031 (estimated)
- Study completion
- 1 Oct 2032 (estimated)
- First posted
- 28 Oct 2026 (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.
The goal of this Randomized Controlled Trial is to learn what machine preservation method is most clinically effective for liver transplantation (LTx) after donation after circulatory death (DCD). The main questions it aims to answer are:
- What perfusion method has the lowest death censored biliary complication rate at 1-year post LT?
- Are there differences in the Core Outcome Set of liver transplantation outcomes?
- Are there any differences in utilization outcomes?
- Are there any differences in cost effectiveness?
- Are there any differences in patient quality of life?
- Are there any differences in resource utilization?
Researchers will compare preservation using in-situ abdominal normothermic regional perfusion (aNRP) to (dual) hypothermic oxygenated perfusion (DHOPE) or DHOPE followed by controlled oxygenated rewarming and normothermic machine perfusion (DHOPE-COR-NMP).
Nothing will change from clinical practice for the liver recipients.
Detailed description
RELEVANCE Around 15% of waiting-list patients for liver transplantation are removed prematurely due to death or clinical deterioration. To reduce donor liver shortage, lower-quality livers are increasingly used, including those from donation after circulatory death (DCD), though these carry a higher risk of complications. Several machine perfusion techniques have been developed to recondition and/or assess donor livers: 'in situ' abdominal Normothermic Regional Perfusion (aNRP), and 'ex-situ' Dual Hypothermic Oxygenated Perfusion (DHOPE), in some cases followed by Controlled Oxygenated Rewarming (COR) and Normothermic Machine perfusion (NMP). All these techniques are reimbursed as proven effective treatment in the Netherlands. It remains unclear which strategy is most effective and cost-efficient for DCD livers. A direct comparison is needed to answer this question and decide on a future standard of care.
RESEARCH QUESTION Which machine perfusion technique is most clinically effective and cost-effective for liver transplantation after DCD?
HYPOTHESIS In situ preservation using aNRP reduces the one year incidence of total biliary complications when compared to ex situ preservation with DHOPE (±COR-NMP), with potential cost advantages.
INTERVENTION In situ perfusion (aNRP), restores oxygenated circulation to abdominal organs shortly after donor cardiac arrest to protect organs and allow functional assessment. In standard risk (SCD)-DCD livers, perfusion is performed for one hour without viability assessment. If (re)classified as high risk (extended criteria or ECD)-DCD liver, perfusion continues for two hours, including viability assessment.
COMPARISON The current standard ex-situ perfusion techniques in DCD liver transplantation: DHOPE for standard-risk SCD-DCD livers; or DHOPE-COR-NMP for ECD-DCD livers.
FOLLOW-UP TIME 60 month inclusion time, 12 month follow-up post-transplantation
STUDY DESIGN Multicenter 1:1 randomized controlled trial. DCD livers will be randomized (Castor EDC) after stratification for type (SCD-DCD or ECD-DCD) and transplantation center. Donor characteristics will be obtained from the Eurotransplant Registry, and perfusion parameters recorded prospectively. Recipient data will be extracted from electronic medical records for mandatory Netherlands Organ Transplant Registry (NOTR) registration.
SAMPLE SIZE \& DATA ANALYSIS SCD-DCD 156 liver transplantations per group, total 312. ECD-DCD 102 liver transplantations per group, total 204. Overall: 516 liver transplantations.
Estimated randomizations: 752 total, approximately 236 procedures/randomisations do not result in transplantation due to long agonal phase and viability assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCD donor livers receiving machine preservation using ex-situ DHOPE +/- COR-NMP | Other | Procedure: Ex-situ perfusion: DHOPE/DHOPE-COR-NMPThis arm contains of 2 pre-defined strata: SCD-DCD livers: receiving DHOPE, ECD-DCD livers: receiving DHOPE-COR-NMP. Both treatments are standard of care. |
| DCD donor livers receiving machine preservation using in-situ aNRP | Other | Procedure: In-situ perfusion: aNRPThis arm contains of 2 pre-defined strata: SCD-DCD livers: receiving 1 hour of aNRP, ECD-DCD livers: receiving 2 hours of aNRP. Both treatments are standard of care. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All DCD donor livers (donor=>16 years) accepted for transplantation in the Netherlands
Key exclusion criteria (2 listed)
- HU recipients
- Logistical or technical constraints for machine perfusion
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 |
|---|---|---|
| In-situ perfusion: aNRPThis arm contains of 2 pre-defined strata: SCD-DCD livers: receiving 1 hour of aNRP, ECD-DCD livers: receiving 2 hours of aNRP. Both treatments are standard of care. | Procedure or surgery | DCD donor livers receiving machine preservation using in-situ aNRP |
| Ex-situ perfusion: DHOPE/DHOPE-COR-NMPThis arm contains of 2 pre-defined strata: SCD-DCD livers: receiving DHOPE, ECD-DCD livers: receiving DHOPE-COR-NMP. Both treatments are standard of care. | Procedure or surgery | DCD donor livers receiving machine preservation using ex-situ DHOPE +/- COR-NMP |
Primary outcome
one-year cumulative incidence of biliary complications
Time frame: 1 year
Death censored incidence of biliary complications including biliary anastomotic strictures, post-transplant cholangiopathy and biliary leakages, all that necessitate intervention
37 secondary outcomes
cost-effectiveness
Time frame: 5 year
Post transplant cholangiopathy rate
Time frame: 1 year
patient QOL
Time frame: 2 year
Patient mortality
Time frame: 1 year
Graft loss
Time frame: 1 year
post-transplant overall complications
Time frame: 1 year
duration of hospital and ICU stay
Time frame: 1 year
Environmental Demand
Time frame: 1 year
Liver utilization rate
Time frame: 1 year
Postoperative intra-abdominal bleeding
Time frame: During index in-hospital stay, on average 9 days
Presence of post reperfusion syndrome
Time frame: During transplantation
Need for renal replacement therapy
Time frame: During index in-hospital stay, on average 9 days
Intervention rates
Time frame: 1 year
Reoperation rate
Time frame: 1 year
Early Allograft Failure Simplified Estimation Score
Time frame: 10 days post operative
Retransplantation rate
Time frame: 1 year
Primary non function rate
Time frame: 14 days
Anastomotic stricture
Time frame: 1 year
Bile leak
Time frame: 1 year
Early allograft dysfunction
Time frame: Postoperative day 7
Death censored graft survival
Time frame: 1 year
Overall graft survival
Time frame: 1 year
Patient survival
Time frame: 1 year
Accumulated team member working hours
Time frame: 1 year
Readmission rate
Time frame: 1 year
Creatinine values
Time frame: 5 years
Sodium values
Time frame: 5 years
Alkaline Phosphatase values
Time frame: 5 years
Alanine Aminotransferase values
Time frame: 5 years
gamma-Glutamyl Transferase values
Time frame: 5 years
Bilirubin values
Time frame: 5 years
Aspartate Aminotransferase values
Time frame: 5 years
International Normalized Ratio values
Time frame: 5 years
Thrombocytes values
Time frame: 5 years
Urea values
Time frame: 5 years
eGFR values
Time frame: 5 years
Utilized organs per donor
Time frame: Peri-operative
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 3 Nov 2026.
- Individual participant dataSharing planned: No. IPD will not be shared. Anonimization of data needs to be addressed to provide sufficient patient and donor privacy according to national law.
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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.
Volkert A Huurman, MD PhD principal investigator
Leiden University Medical Center, Department of Surgery
Jeroen de Jonge, MD PhD principal investigator
Erasmus Medical Center
Vincent E de Meijer, MD PhD principal investigator
University Medical Center Groningen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-situ perfusion: aNRP and Ex-situ perfusion: DHOPE/DHOPE-COR-NMP in people with Liver Disease (Alcoholic or Not) and Transplantation, run by Leiden University Medical Center at 3 sites 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 2 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Volkert A Huurman, MD PhD (+31-624801027, v.a.l.huurman@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one-year cumulative incidence of biliary complications (time frame: 1 year). 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 3 Nov 2026.