Liver DiseasesNCT04483102
RESTORE Declined Livers Study
A study testing Declined liver in Normothermic Machine Perfusion (NMP) and Standard cold preservation of liver in people with Liver Diseases and Surgery, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This is a prospective, non-randomized, clinical trial of discarded liver transplants that have received normothermic machine perfusion (NMP), compared with standard cold preservation liver transplants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Surgery, Transplant; Failure, Liver
- What is being tested?
- Declined liver in Normothermic Machine Perfusion (NMP) and Standard cold preservation of liver
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2020to 14 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- DCD donor aged 6 years or greater and liver weight between 1 kg and 3.4 kg, with functional warm ischemic time (defined as the period between the systolic blood pressure less than 60 mmHg to the time of commencing donor aortic perfusion) in DCD donors less than 40 minutes
- DCD asystolic warm ischemia time (from heartbeat stopping to initiation of cold flush) less than 15 minutes
- DBD donor aged 6 years or greater and liver weight between 1 kg and 3.4 kg, with less than 8 hours cold ischemia time and DCD livers with less than 7 hours cold ischemia time (defined as the interim from initiation of donor in vivo cold organ preservation to removal of the liver graft from cold storage)
- 'Rapid Recovery' donors for liver procurement, meeting the above criteria
- Suboptimal in situ flush
- Subject must be greater than or equal to 18 years of age.
Show all 10Show fewer
- Subject with end-stage liver disease who is actively listed for primary liver transplantation on the UNOS waiting list
- Subject, or a legally authorized representative, has given informed consent to participate in the study
- Subject has a frailty classification of "Mild frailty/No frailty (Robust)", based on the Liver Frailty Index (LFI), which has been assessed within 6 months prior to liver transplant OR Subject is able to perform >350 m on a 6 minute walk test (6MWT) within 6 months prior to liver transplant.
- In all cases, the "most recent" (and within 6 months prior to transplant) measurement of LFI or 6MWT will be used to determine eligibility.
Who cannot join
- DBD or DCD donor less than 6 years old
- DCD grafts with donor functional warm ischemic time (defined as the period between the systolic blood pressure less than 60 mmHg to the time of commencing donor aortic perfusion) greater than or equal to 40 minutes
- DCD asystolic warm ischemia time (from heartbeat stopping to initiation of cold flush) greater than or equal to 15 minutes
- DBD livers with cold ischemia time greater than or equal to 8 hours and DCD livers with greater than or equal to 7 hours cold ischemia time
- Donor serum bilirubin greater than or equal to 5 mg/dL
- Liver weight less than 1 kg or greater than or equal to 3.5 kg
Show all 16Show fewer
- Grafts from patients with HIV infection
- Cirrhotic livers
- Livers with bridging fibrosis
- LIVER TRANSPLANTATION - HUMAN
- Subject is currently listed as a UNOS status 1A.
- Subject is requiring oxygen therapy via ventilator/respiratory support.
- Subject is planned to undergo simultaneous solid organ transplant.
- Subject is pregnant at the time of transplant.
- Subject MELD score 29 or higher
- Subject receives re-transplantation of liver.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Prospective, Single-Center, Non-Randomized, Clinical Trial of Transplantation of Discarded Livers Using Normothermic Machine Perfusion (NMP)
This is a prospective, non-randomized, clinical trial of discarded liver transplants that have received normothermic machine perfusion (NMP), compared with standard cold preservation liver transplants. The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study. Liver transplant outcomes will be ascertained during 12 months post-transplantation. The results of the trial will be compared with those of contemporary comparison groups of patients who received the standard criteria donor liver transplantation.
Read the detailed description
This is a single center, prospective, non-randomized, clinical trial to assess the feasibility of successful transplantation of NMP-treated livers to patients. First, up to 71 marginal livers declined for transplantation will be treated with NMP using the OrganOx® metra device and tested for viability using previously defined criteria. NMP-treated viable livers will be subsequently transplanted to patients (n=5 in the 1st stage; additional 10 transplantation in the 2nd stage; additional 10 transplantation in the 3rd stage: total N=25). Patients will be closely followed for clinical outcomes of the transplantation during 6 months post-transplantation. The follow-up will also be extended up to 1 year post-transplantation. The trial will compare the results to those of three comparison groups - 1) matched patients who received liver transplantation at Washington University/Barnes Jewish Hospital; 2) matched patients who received DBD liver transplantation in the OPTN/UNOS database; and 3) matched patients who received DCD liver transplantation in the OPTN/UNOS database. Given that patient safety is the priority, the trial uses a multi-stage design in which the study stops earlier when NMP-treated liver transplantation is observed to be ineffective (see trial schema in Section 3.1).
- Conditions
- Liver Diseases, Surgery, Transplant; Failure, Liver
- Being tested
- Declined liver in Normothermic Machine Perfusion (NMP), Standard cold preservation of liver
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Declined liver in Normothermic Machine Perfusion (NMP)Device
Also called NMP-treated livers
The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study.
Standard cold preservation of liverProcedure or surgery
The study will have three comparison groups - one local comparison group and two comparison groups from the national UNOS data.
Comparison group 1 will be patients who received a standard liver transplantation and follow-up care at the Washington University/ Barnes Jewish Hospital (n=50). Patients will be matched by a 5-year age category, sex, MELD score, donor liver graft type (e.g., DCD, DBD), donor age (5-year category), and donor sex. Washington University/ Barnes Jewish Hospital maintains a liver transplantation database that prospectively collects pre- and post-transplantation patient data.
Comparison group 2 will be patients who received DBD liver transplantation in the OPTN/UNOS database (n=100). Patients will be matched by age, sex, MELD score, donor age, and donor sex.
Comparison group 3 will be patients who received DCD liver transplantation in the OPTN/UNOS database (n=100). Patients will be matched by age, sex, MELD score, donor age, and donor sex.
| Study group | Role | What they receive |
|---|---|---|
| Declined liver in Normothermic Machine Perfusion (NMP) | Experimental | The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study. NMP of the donated declined liver utilizing the OrganOx® metra device. NMP involves (warm) machine perfusion with oxygenated blood at normal body temperature. During NMP, the device also allows for ongoing assessment of donor liver function and further viability assessment to help determine suitability of the organ for transplant. Receives: Device: Declined liver in Normothermic Machine Perfusion (NMP) |
| Standard cold preservation of liver | Active comparator | This group will receive liver transplant using the standard method of preservation. There will be 3 comparison groups: one local comparison group and two comparison groups from the national UNOS data. Receives: Procedure: Standard cold preservation of liver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With no Graft Failure at 6 Months
6-month graft survival as an indicator of liver function after NMP- treated liver transplantation.
This is a nationally accepted outcome routinely assessed in organ transplantation programs.
6-month graft survival rate = (Number of patients with no graft failure at 6-month post transplantation)/(Total number patients who received transplantation with NMP-treated liver)
Measured: Up to 6 months
6-month Patient Survival
6-month patient survival rate = (Number of patients who survive by 6-month post transplantation)/(Total number patients in the cohort who received transplantation)
Measured: Up to 6 months
Secondary outcomes (16)
Liver Graft Function Assessment: Early Allograft Dysfunction
The presence of one or more of the following will be defined as early allograft dysfunction (EAD): bilirubin greater than or equal to 10 mg/dL on day 7*, international normalized ratio greater than or equal to 1.6 on day 7*, and alanine or aspartate aminotransferases greater than 2000 IU/L within the first 7 days*. (* day 7 or discharge, whichever occurs first).
EAD = (Number of patients who experienced EAD)/(Total number patients who received transplantation with NMP-treated liver)
Measured: First 7 days
Liver Graft Function Assessment: Primary Non-Function (PNF)
If one of the following criteria is met, and in the absence of a technical reason for graft failure, e.g. hepatic arterial thrombosis, and the subject requires re-listing for re-transplantation, it will be defined as primary non-function of a transplanted liver within 7 days of implantation if: 1) AST greater than or equal to 3000 and one or both of a) INR greater than or equal to 2.5 and b) acidosis (arterial pH less than or equal to 7.30 or venous pH less than or equal to 7.25 and/or lactate greater than or equal to 4 mmol/L); 2) anhepatic candidate.
PNF= (number of participants that experienced PNF/ total number of patients who received transplantation with NMP-treated liver)
Measured: First 7 days
No Graft Failure at 90 Days
90-day graft survival= (number of patients with no graft failure at 90 days/total number of patients who received transplantation with NMP-treated liver)
Measured: 3 months
90-day Patient Survival
90 day patient survival= (Number of patients who survived by 90 days/ number of patients who received transplantation with NMP-treated liver)
Measured: 3 months
Number of Patients With no Graft Failure at 12 Months
12 Month Graft Survival: (Number of patients with no graft failure at 12 months / number of patients who received transplantation with NMP-treated liver)
Measured: 12 months
12-Month Patient Survival
12-month patient survival rate = (Number of patients who survive by 12-month post transplantation)/(Total number patients in the cohort who received transplantation)
Measured: 12 months
Incidence of Intrahepatic Biliary Strictures
Number of patients who experienced intrahepatic biliary strictures / Number of patients who received transplantation with NMP-treated liver
Measured: 12 Months
Incidence of Vascular Complications
Number of patients that experienced vascular complications / number of patients who received transplantation with NMP-treated liver
Measured: 0-12 months
Event Rate of Requirement of Renal Replacement Therapy
Number of patients that required renal replacement therapy / number of patients who received transplantation with NMP-treated liver
Measured: 0-12 Months
Incidence of Biopsy-Proven Acute Rejection
Number of patients that experienced acute rejection / number of patients who received transplantation with NMP-treated liver
Measured: 0-12 months
Event Rate of Transplant Related Reoperation Rate
Number of patients that experienced transplant related reoperation / number of patients who received transplantation with NMP-treated liver
For graft related complications that more specifically target the transplanted liver allograft and associated structures (e.g. bile duct, hepatic artery, portal vein, hepatic duct, hepatic vein, inferior vena cava)
Measured: 0-12 Months
Length of ICU Stay
The number of days the patient was in the ICU post-transplant
Measured: 0-3 Months
Length of Hospital Stay
Number of days the patient was hospitalized after transplantation.
Measured: 0-2 Months
Event Rate of Readmissions
Number of patients that experienced a hospital readmission / number of patients who received transplantation with NMP-treated liver
Measured: 0-12 Months
Quality of Life Score
EQ-5D-5L administered, which assessed the following domains:
Mobility- minimum vale (I have no problems walking) and maximum value (I am unable to walk) Self-Care- minimum vale (I have no problems washing or dressing myself) and maximum value (I am unable to wash or dress myself) Usual Activities- minimum vale (I have no problems doing my usual activities) and maximum value (I am unable to do my usual activities) Pain/Discomfort- minimum vale (I have no pain or discomfort) and maximum value (I have extreme pain or discomfort) Anxiety/Depression- minimum vale (I am not anxious or depressed) and maximum value (I am extremely anxious or depressed) *for above, minimum values considered a better outcome
How good or bad your health is today- minimum value 0 (worst health you can imagine) and maximum value 100 (best health you can imagine)
*for above, maximum value considered a better outcome
Measured: 0-6 Months
NMP-treated Liver Rescue Rate
Rescue Rate = (number of viable NMP- treated livers / total number of NMP-treated livers)
Measured: course of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start3 Dec 2020
- Primary completion14 May 2025
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- To successfully transplant NMP-treated livers to patients that would otherwise have been discarded.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Mid-America Transplant, OrganOx Ltd.
- Responsible party
- Sponsor
- Investigators
- Will Chapman, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483102
- Sponsor's protocol ID
- 202007093
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2020
- Last updated
- 23 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Olumba FC, Zhou F, Park Y, Chapman WC; RESTORE Investigators Group. Normothermic Machine Perfusion for Declined Livers: A Strategy to Rescue Marginal Livers for Transplantation. J Am Coll Surg. 2023 Apr 1;236(4):614-625. doi: 10.1097/XCS.0000000000000555. Epub 2023 Jan 11.
PubMed 36728302
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Non-Randomized, Clinical Trial of Transplantation of Discarded Livers Using Normothermic Machine Perfusion (NMP)
- ClinicalTrials.gov ID
- NCT04483102
- Acronym / sponsor ID
- 202007093
- Conditions
- Liver Diseases, Surgery, Transplant; Failure, Liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Mid-America Transplant, OrganOx Ltd.
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Posted 23 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, non-randomized, clinical trial of discarded liver transplants that have received normothermic machine perfusion (NMP), compared with standard cold preservation liver transplants. The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study. Liver transplant outcomes will be ascertained during 12 months post-transplantation. The results of the trial will be compared with those of contemporary comparison groups of patients who received the standard criteria donor liver transplantation.
Detailed description
This is a single center, prospective, non-randomized, clinical trial to assess the feasibility of successful transplantation of NMP-treated livers to patients. First, up to 71 marginal livers declined for transplantation will be treated with NMP using the OrganOx® metra device and tested for viability using previously defined criteria. NMP-treated viable livers will be subsequently transplanted to patients (n=5 in the 1st stage; additional 10 transplantation in the 2nd stage; additional 10 transplantation in the 3rd stage: total N=25). Patients will be closely followed for clinical outcomes of the transplantation during 6 months post-transplantation. The follow-up will also be extended up to 1 year post-transplantation. The trial will compare the results to those of three comparison groups - 1) matched patients who received liver transplantation at Washington University/Barnes Jewish Hospital; 2) matched patients who received DBD liver transplantation in the OPTN/UNOS database; and 3) matched patients who received DCD liver transplantation in the OPTN/UNOS database. Given that patient safety is the priority, the trial uses a multi-stage design in which the study stops earlier when NMP-treated liver transplantation is observed to be ineffective (see trial schema in Section 3.1).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To successfully transplant NMP-treated livers to patients that would otherwise have been discarded.
| Arm | Type | Receives |
|---|---|---|
| Declined liver in Normothermic Machine Perfusion (NMP) | Experimental | Device: Declined liver in Normothermic Machine Perfusion (NMP)The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study. NMP of the donated declined liver utilizing the OrganOx® metra device. NMP involves (warm) machine perfusion with oxygenated blood at normal body temperature. During NMP, the device also allows for ongoing assessment of donor liver function and further viability assessment to help determine suitability of the organ for transplant. |
| Standard cold preservation of liver | Active comparator | Procedure: Standard cold preservation of liverThis group will receive liver transplant using the standard method of preservation. There will be 3 comparison groups: one local comparison group and two comparison groups from the national UNOS data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- DCD donor aged 6 years or greater and liver weight between 1 kg and 3.4 kg, with functional warm ischemic time (defined as the period between the systolic blood pressure less than 60 mmHg to the time of commencing donor aortic perfusion) in DCD donors less than 40 minutes
- DCD asystolic warm ischemia time (from heartbeat stopping to initiation of cold flush) less than 15 minutes
- DBD donor aged 6 years or greater and liver weight between 1 kg and 3.4 kg, with less than 8 hours cold ischemia time and DCD livers with less than 7 hours cold ischemia time (defined as the interim from initiation of donor in vivo cold organ preservation to removal of the liver graft from cold storage)
- 'Rapid Recovery' donors for liver procurement, meeting the above criteria
- Suboptimal in situ flush
Key exclusion criteria (16 listed)
- DBD or DCD donor less than 6 years old
- DCD grafts with donor functional warm ischemic time (defined as the period between the systolic blood pressure less than 60 mmHg to the time of commencing donor aortic perfusion) greater than or equal to 40 minutes
- DCD asystolic warm ischemia time (from heartbeat stopping to initiation of cold flush) greater than or equal to 15 minutes
- DBD livers with cold ischemia time greater than or equal to 8 hours and DCD livers with greater than or equal to 7 hours cold ischemia time
- Donor serum bilirubin greater than or equal to 5 mg/dL
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 |
|---|---|---|
| Declined liver in Normothermic Machine Perfusion (NMP)Also: NMP-treated liversThe discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study. | Device | Declined liver in Normothermic Machine Perfusion (NMP) |
| Standard cold preservation of liverThe study will have three comparison groups - one local comparison group and two comparison groups from the national UNOS data. Comparison group 1 will be patients who received a standard liver transplantation and follow-up care at the Washington University/ Barnes Jewish Hospital (n=50). Patients will be matched by a 5-year age category, sex, MELD score, donor liver graft type (e.g., DCD, DBD), donor age (5-year category), and donor sex. Washington University/ Barnes Jewish Hospital maintains a liver transplantation database that prospectively collects pre- and post-transplantation patient data. Comparison group 2 will be patients who received DBD liver transplantation in the OPTN/UNOS database (n=100). Patients will be matched by age, sex, MELD score, donor age, and donor sex. Comparison group 3 will be patients who received DCD liver transplantation in the OPTN/UNOS database (n=100). Patients will be matched by age, sex, MELD score, donor age, and donor sex. | Procedure or surgery | Standard cold preservation of liver |
Primary outcome
Number of Patients With no Graft Failure at 6 Months
Time frame: Up to 6 months
6-month graft survival as an indicator of liver function after NMP- treated liver transplantation. This is a nationally accepted outcome routinely assessed in organ transplantation programs. 6-month graft survival rate = (Number of patients with no graft failure at 6-month post transplantation)/(Total number patients who received transplantation with NMP-treated liver)
6-month Patient Survival
Time frame: Up to 6 months
6-month patient survival rate = (Number of patients who survive by 6-month post transplantation)/(Total number patients in the cohort who received transplantation)
16 secondary outcomes
Liver Graft Function Assessment: Early Allograft Dysfunction
Time frame: First 7 days
Liver Graft Function Assessment: Primary Non-Function (PNF)
Time frame: First 7 days
No Graft Failure at 90 Days
Time frame: 3 months
90-day Patient Survival
Time frame: 3 months
Number of Patients With no Graft Failure at 12 Months
Time frame: 12 months
12-Month Patient Survival
Time frame: 12 months
Incidence of Intrahepatic Biliary Strictures
Time frame: 12 Months
Incidence of Vascular Complications
Time frame: 0-12 months
Event Rate of Requirement of Renal Replacement Therapy
Time frame: 0-12 Months
Incidence of Biopsy-Proven Acute Rejection
Time frame: 0-12 months
Event Rate of Transplant Related Reoperation Rate
Time frame: 0-12 Months
Length of ICU Stay
Time frame: 0-3 Months
Length of Hospital Stay
Time frame: 0-2 Months
Event Rate of Readmissions
Time frame: 0-12 Months
Quality of Life Score
Time frame: 0-6 Months
NMP-treated Liver Rescue Rate
Time frame: course of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36728302Olumba FC, Zhou F, Park Y, Chapman WC; RESTORE Investigators Group. Normothermic Machine Perfusion for Declined Livers: A Strategy to Rescue Marginal Livers for Transplantation. J Am Coll Surg. 2023 Apr 1;236(4):614-625. doi: 10.1097/XCS.0000000000000555. Epub 2023 Jan 11.
- Individual participant dataSharing planned: No
Related trials for Liver Diseases
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
Not yet recruitingPhase 3
Personalized Adaptive Radiotherapy for Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC)
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. This study is not recruiting at the moment.
Will Chapman, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Declined liver in Normothermic Machine Perfusion (NMP) and Standard cold preservation of liver in people with Liver Diseases and Surgery, run by Washington University School of Medicine at 1 site in United States.
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 10 inclusion and 16 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: finished, as of the sponsor's last update on 23 Sep 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 23 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With no Graft Failure at 6 Months (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04483102, which also lists 1 linked publication.
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 23 Sep 2026.