Liver TransplantationVITTALNCT02740608
Viability Testing and Transplantation of Marginal Livers
A study testing OrganOx metra in people with Liver Transplantation, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
This study is designed to determine if a rejected liver is viable using normothermic machine liver perfusion (NMLP). It aims to 1. establish the suitability of livers which have been declined by all UK liver transplant centres by monitoring their function on the NMLP machine; and, 2. 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?
- OrganOx metra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Oct 2016to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Liver from a donor primary accepted with the intention for a clinical transplantation
- Liver graft was rejected by all the other UK transplant centres via normal or fast-track sequence
- Cold ischaemic time less than 16 hours for DBD and 10 hours for DCD grafts
- One of the following parameters capturing the objectivity of the liver high-risk status
- Donor risk index greater than 2.0
- Graft steatosis greater than 30%
Show all 14Show fewer
- BAR score greater than 9;
- Donor warm ischaemic time greater than 30 minutes
- Anticipated cold ischaemic time greater than 12 hours for DBD or 8 hours for DCD liver grafts
- Suboptimal liver graft perfusion documented by a photo of macroscopic appearance
- Liver transaminases (ALT or AST) above 1000 IU/mL
- Adult primary liver transplant recipient
- Patient listed electively for transplantation
- Low to moderate transplant risk candidate, suitable for marginal graft, as assessed by the UHB liver transplant listing MDT meeting (these are usually candidates with low UKELD score, without cardiovascular comorbidities, with good functional and nutrition status, with patent portal vein and with no history of previous major upper abdominal surgery, e.g. patients transplanted for liver cancer)
Who cannot join
- Grafts from patients with active Hepatitis B, C or HIV infection
- Livers with cirrhotic macroscopic appearance
- Livers with advanced fibrosis
- DCD grafts with donor warm ischaemic time (systolic blood pressure less than 50mmHg to aortic perfusion) more than 60 minutes
- Excessive cold ischaemic times (DBD more than 16 hours / DCD more than 10 hours)
- Criteria for transplantation:
Show all 16Show fewer
- Evidence of bile production
- Perfusate lactate levels less than or equal to 2.5 mmol/L 3. pH greater than 7.30
- 4. Metabolism of glucose 5. Stable arterial flow of more than 150 mL/ minute and portal flow more than 500 mL/minute 6. Homogeneous graft perfusion with soft consistency of the parenchyma
- Subjects who meet any of the following exclusion criteria are excluded from participating in the VITTAL trial:
- High-risk patients and recipients not suitable for a marginal graft (these are mainly patients with high UKELD score (>62 as per the NHSBT LAG criteria for graft sharing in highrisks recipients in the North East of the UK [http://www.odt.nhs.uk/pdf/advisory.../Liver_National_Allocation_Scheme.pdf]), with cardiovascular comorbidities or renal insufficiency, with poor nutrition and performance status or history of major upper abdominal surgery, e.g. patients listed for liver re-transplantation)
- Patients with complete portal vein thrombosis diagnosed prior to the transplantation
- Liver re-transplantation
- Patients with fulminant hepatic failure
- Patients undergoing transplantation of more than one organ
- Contraindication to magnetic resonance imaging (i.e. pacemaker fitted)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
UHBFT - Queen Elizabeth Hospital, Birmingham
Birmingham, B15 2TT
About this study
Official title: An Open Label, Non-randomised, Prospective, Single Arm, 2-part Trial, Using Normothermic Machine Liver Perfusion NMLP to Test Viability and Transplantation of Marginal Livers
This study is designed to determine if a rejected liver is viable using normothermic machine liver perfusion (NMLP). It aims to
- establish the suitability of livers which have been declined by all UK liver transplant centres by monitoring their function on the NMLP machine; and,
- transplant the liver if its function on the machine is satisfactory allowing it to be transplanted.
Read the detailed description
Deaths from liver disease have soared by 40 per cent in a decade and continue to rise. Liver transplantation is a highly successful treatment of end stage liver disease, fulminant hepatic failure and early stage primary liver cancer. The demand for donor livers for transplantation greatly exceeds supply and approximately 20% of patients die whilst awaiting transplantation. Normothermic machine liver perfusion (NMLP) is a novel technique developed for the purposes of organ preservation, which we have also found allows monitoring of liver graft function ex-vivo by measuring bile production, whilst permitting objective assessment of liver biochemistry and blood flow. The OrganOx metra, the NMLP device we are using, is CE marked but is not currently licensed for this particular use and the livers will not be transported using this device (which the CE mark currently covers). The device will be used at a particular site (in this case University Hospitals Birmingham) and after a period of static cold storage during which the liver will be transported to the hospital for testing on the device. The study population will be extended criteria donor livers, rejected for transplantation by all UK centres, which are then found to be functioning during perfusion and transplanted into "medium to low-risk" liver transplant recipients. VITTAL is an open label, non-randomised, prospective, single arm, 2-part trial the objectives of which are to:
- Further validate liver viability assessment criteria
- Perform the phase 2 study transplanting successfully resuscitated "rejected" livers
- Establish the feasibility of NMLP as a means to increase the number of transplantable livers.
- Identify novel biomarkers that are indicative of liver quality and function In terms of intervention, the procurement and transplantation of the organs will follow the current standard of care. The only deviation from the current standard will be the normothermic perfusion of organs following static cold storage in order to test their ability to function. This study is based on results from a 5-case pilot series which transplanted low-risk recipients with organs that had been rejected for transplantation but had been shown to function on the normothermic machine perfusion device. This work is currently in the process of being published. The main risk would be the transplantation of a non-functioning graft (resulting in a case of primary non-function that could result in re-transplantation or patient death.) Based on our pre-clinical research and clinical pilot series we believe the criteria we have identified that indicate organ function are stringent and significantly reduce this risk.
- Conditions
- Liver Transplantation
- Being tested
- OrganOx metra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrganOx metraDevice
Normothermic Machine Liver Perfusion
| Study group | Role | What they receive |
|---|---|---|
| Liver transplantation | Other | All Participants will receive liver transplantation using the OrganOx metra device Receives: Device: OrganOx metra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival
Achievement of successful transplantation of previously rejected donor liver following viability testing using NMLP
Measured: 90 days
Use of NMLP to identify the proportion of transplantable liver grafts from the currently rejected donor organ pool.
Decision point of using graft in patient transplantation
Measured: Approximately 6 hours
Secondary outcomes (3)
Liver graft function
Assess the liver graft function following transplantation (by incidence of primary non-function, and early allograft dysfunction) by
- Liver function tests
- 90-day graft survival
- 12-month patient and graft survival The secondary endpoints and other outcome measures will be compared with a contemporary matched recipient group
Measured: 12 month
Morbidity associated with receipt of extended criteria graft
Assess morbidity associated with receipt of extended criteria graft that had previously been rejected by
- Adverse event rates and severity
- Requirement of renal replacement therapy
- Incidence of biliary complications
- Incidence of vascular complications
- Biopsy-proven acute rejection
- Reoperation rate
- Length of intensive therapy unit stay
- Length of hospital stay
Measured: 90 days
Physiological response to reperfusion of the perfused grafts
Assess the physiological response to reperfusion of the perfused grafts by
- Post-reperfusion syndrome (Defined as a decrease in mean arterial pressure (MAP) of more than 30% from the baseline value for more than one minute during the first five minutes after reperfusion (assessed in the context of inotrope use)
Measured: Approximately 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study start6 Oct 2016
- Primary completion8 May 2018
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, University Hospital Birmingham NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Darius Mirza, Principal investigator, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740608
- Sponsor's protocol ID
- RG_15_240
- Other IDs
- 2016-001250-18, 2016
- Acronym
- VITTAL
- Status last verified
- Feb 2022
- First submitted
- 12 Apr 2016
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Laing RW, Mergental H, Yap C, Kirkham A, Whilku M, Barton D, Curbishley S, Boteon YL, Neil DA, Hubscher SG, Perera MTPR, Muiesan P, Isaac J, Roberts KJ, Cilliers H, Afford SC, Mirza DF. Viability testing and transplantation of marginal livers (VITTAL) using normothermic machine perfusion: study protocol for an open-label, non-randomised, prospective, single-arm trial. BMJ Open. 2017 Nov 28;7(11):e017733. doi: 10.1136/bmjopen-2017-017733.
PubMed 29183928Mergental H, Laing RW, Hodson J, Boteon YL, Attard JA, Walace LL, Neil DAH, Barton D, Schlegel A, Muiesan P, Abradelo M, Isaac JR, Roberts K, Perera MTPR, Afford SC, Mirza DF. Introduction of the Concept of Diagnostic Sensitivity and Specificity of Normothermic Perfusion Protocols to Assess High-Risk Donor Livers. Liver Transpl. 2022 May;28(5):794-806. doi: 10.1002/lt.26326. Epub 2021 Nov 9.
PubMed 34619014Mergental H, Laing RW, Afford SC, Mirza DF. Reply to 'Hypothermic machine perfusion before viability testing of previously discarded human livers'. Nat Commun. 2021 Feb 12;12(1):1015. doi: 10.1038/s41467-021-21183-7. No abstract available.
PubMed 33579911Neil DAH, Mergental H, Hann A, Laing RW, Hartog H, Mirza DF, Perera MTPR. Is Hepatocyte Necrosis a Good Marker of Donor Liver Viability During Machine Perfusion? Hepatol Commun. 2022 Feb;6(2):435-436. doi: 10.1002/hep4.1816. Epub 2021 Sep 2. No abstract available.
PubMed 34558864Attard JA, Osei-Bordom DC, Boteon Y, Wallace L, Ronca V, Reynolds G, Perera MTPR, Oo YH, Mergental H, Mirza DF, Afford SC. Ex situ Normothermic Split Liver Machine Perfusion: Protocol for Robust Comparative Controls in Liver Function Assessment Suitable for Evaluation of Novel Therapeutic Interventions in the Pre-clinical Setting. Front Surg. 2021 Feb 17;8:627332. doi: 10.3389/fsurg.2021.627332. eCollection 2021.
PubMed 33681282Mergental H, Laing RW, Kirkham AJ, Perera MTPR, Boteon YL, Attard J, Barton D, Curbishley S, Wilkhu M, Neil DAH, Hubscher SG, Muiesan P, Isaac JR, Roberts KJ, Abradelo M, Schlegel A, Ferguson J, Cilliers H, Bion J, Adams DH, Morris C, Friend PJ, Yap C, Afford SC, Mirza DF. Transplantation of discarded livers following viability testing with normothermic machine perfusion. Nat Commun. 2020 Jun 16;11(1):2939. doi: 10.1038/s41467-020-16251-3.
PubMed 32546694Mergental H, Laing RW, Kirkham AJ, Clarke G, Boteon YL, Barton D, Neil DAH, Isaac JR, Roberts KJ, Abradelo M, Schlegel A, Dasari BVM, Ferguson JW, Cilliers H, Morris C, Friend PJ, Yap C, Afford SC, Perera MTPR, Mirza DF. Discarded livers tested by normothermic machine perfusion in the VITTAL trial: Secondary end points and 5-year outcomes. Liver Transpl. 2024 Jan 1;30(1):30-45. doi: 10.1097/LVT.0000000000000270. Epub 2023 Dec 15.
PubMed 38109282
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Non-randomised, Prospective, Single Arm, 2-part Trial, Using Normothermic Machine Liver Perfusion NMLP to Test Viability and Transplantation of Marginal Livers
- ClinicalTrials.gov ID
- NCT02740608
- Acronym / sponsor ID
- VITTAL / RG_15_240
- Conditions
- Liver Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Wellcome Trust, University Hospital Birmingham NHS Foundation Trust
- Study start
- 6 Oct 2016 (actual)
- Primary completion
- 8 May 2018 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 15 Apr 2016 (estimated)
- 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.
This study is designed to determine if a rejected liver is viable using normothermic machine liver perfusion (NMLP). It aims to
- establish the suitability of livers which have been declined by all UK liver transplant centres by monitoring their function on the NMLP machine; and,
- transplant the liver if its function on the machine is satisfactory allowing it to be transplanted.
Detailed description
Deaths from liver disease have soared by 40 per cent in a decade and continue to rise. Liver transplantation is a highly successful treatment of end stage liver disease, fulminant hepatic failure and early stage primary liver cancer. The demand for donor livers for transplantation greatly exceeds supply and approximately 20% of patients die whilst awaiting transplantation. Normothermic machine liver perfusion (NMLP) is a novel technique developed for the purposes of organ preservation, which we have also found allows monitoring of liver graft function ex-vivo by measuring bile production, whilst permitting objective assessment of liver biochemistry and blood flow. The OrganOx metra, the NMLP device we are using, is CE marked but is not currently licensed for this particular use and the livers will not be transported using this device (which the CE mark currently covers). The device will be used at a particular site (in this case University Hospitals Birmingham) and after a period of static cold storage during which the liver will be transported to the hospital for testing on the device. The study population will be extended criteria donor livers, rejected for transplantation by all UK centres, which are then found to be functioning during perfusion and transplanted into "medium to low-risk" liver transplant recipients. VITTAL is an open label, non-randomised, prospective, single arm, 2-part trial the objectives of which are to:
- Further validate liver viability assessment criteria
- Perform the phase 2 study transplanting successfully resuscitated "rejected" livers
- Establish the feasibility of NMLP as a means to increase the number of transplantable livers.
- Identify novel biomarkers that are indicative of liver quality and function In terms of intervention, the procurement and transplantation of the organs will follow the current standard of care. The only deviation from the current standard will be the normothermic perfusion of organs following static cold storage in order to test their ability to function. This study is based on results from a 5-case pilot series which transplanted low-risk recipients with organs that had been rejected for transplantation but had been shown to function on the normothermic machine perfusion device. This work is currently in the process of being published. The main risk would be the transplantation of a non-functioning graft (resulting in a case of primary non-function that could result in re-transplantation or patient death.) Based on our pre-clinical research and clinical pilot series we believe the criteria we have identified that indicate organ function are stringent and significantly reduce this risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplantation | Other | Device: OrganOx metraAll Participants will receive liver transplantation using the OrganOx metra device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Liver from a donor primary accepted with the intention for a clinical transplantation
- Liver graft was rejected by all the other UK transplant centres via normal or fast-track sequence
- Cold ischaemic time less than 16 hours for DBD and 10 hours for DCD grafts
- One of the following parameters capturing the objectivity of the liver high-risk status
- Adult primary liver transplant recipient
Key exclusion criteria (16 listed)
- Grafts from patients with active Hepatitis B, C or HIV infection
- Livers with cirrhotic macroscopic appearance
- Livers with advanced fibrosis
- DCD grafts with donor warm ischaemic time (systolic blood pressure less than 50mmHg to aortic perfusion) more than 60 minutes
- Excessive cold ischaemic times (DBD more than 16 hours / DCD more than 10 hours)
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 |
|---|---|---|
| OrganOx metraNormothermic Machine Liver Perfusion | Device | Liver transplantation |
Primary outcome
Patient survival
Time frame: 90 days
Achievement of successful transplantation of previously rejected donor liver following viability testing using NMLP
Use of NMLP to identify the proportion of transplantable liver grafts from the currently rejected donor organ pool.
Time frame: Approximately 6 hours
Decision point of using graft in patient transplantation
3 secondary outcomes
Liver graft function
Time frame: 12 month
Morbidity associated with receipt of extended criteria graft
Time frame: 90 days
Physiological response to reperfusion of the perfused grafts
Time frame: Approximately 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Background: PubMed 29183928Laing RW, Mergental H, Yap C, Kirkham A, Whilku M, Barton D, Curbishley S, Boteon YL, Neil DA, Hubscher SG, Perera MTPR, Muiesan P, Isaac J, Roberts KJ, Cilliers H, Afford SC, Mirza DF. Viability testing and transplantation of marginal livers (VITTAL) using normothermic machine perfusion: study protocol for an open-label, non-randomised, prospective, single-arm trial. BMJ Open. 2017 Nov 28;7(11):e017733. doi: 10.1136/bmjopen-2017-017733.
- Background: PubMed 34619014Mergental H, Laing RW, Hodson J, Boteon YL, Attard JA, Walace LL, Neil DAH, Barton D, Schlegel A, Muiesan P, Abradelo M, Isaac JR, Roberts K, Perera MTPR, Afford SC, Mirza DF. Introduction of the Concept of Diagnostic Sensitivity and Specificity of Normothermic Perfusion Protocols to Assess High-Risk Donor Livers. Liver Transpl. 2022 May;28(5):794-806. doi: 10.1002/lt.26326. Epub 2021 Nov 9.
- Background: PubMed 33579911Mergental H, Laing RW, Afford SC, Mirza DF. Reply to 'Hypothermic machine perfusion before viability testing of previously discarded human livers'. Nat Commun. 2021 Feb 12;12(1):1015. doi: 10.1038/s41467-021-21183-7. No abstract available.
- Background: PubMed 34558864Neil DAH, Mergental H, Hann A, Laing RW, Hartog H, Mirza DF, Perera MTPR. Is Hepatocyte Necrosis a Good Marker of Donor Liver Viability During Machine Perfusion? Hepatol Commun. 2022 Feb;6(2):435-436. doi: 10.1002/hep4.1816. Epub 2021 Sep 2. No abstract available.
- Background: PubMed 33681282Attard JA, Osei-Bordom DC, Boteon Y, Wallace L, Ronca V, Reynolds G, Perera MTPR, Oo YH, Mergental H, Mirza DF, Afford SC. Ex situ Normothermic Split Liver Machine Perfusion: Protocol for Robust Comparative Controls in Liver Function Assessment Suitable for Evaluation of Novel Therapeutic Interventions in the Pre-clinical Setting. Front Surg. 2021 Feb 17;8:627332. doi: 10.3389/fsurg.2021.627332. eCollection 2021.
- Results publication: PubMed 32546694Mergental H, Laing RW, Kirkham AJ, Perera MTPR, Boteon YL, Attard J, Barton D, Curbishley S, Wilkhu M, Neil DAH, Hubscher SG, Muiesan P, Isaac JR, Roberts KJ, Abradelo M, Schlegel A, Ferguson J, Cilliers H, Bion J, Adams DH, Morris C, Friend PJ, Yap C, Afford SC, Mirza DF. Transplantation of discarded livers following viability testing with normothermic machine perfusion. Nat Commun. 2020 Jun 16;11(1):2939. doi: 10.1038/s41467-020-16251-3.
- Derived from this study: PubMed 38109282Mergental H, Laing RW, Kirkham AJ, Clarke G, Boteon YL, Barton D, Neil DAH, Isaac JR, Roberts KJ, Abradelo M, Schlegel A, Dasari BVM, Ferguson JW, Cilliers H, Morris C, Friend PJ, Yap C, Afford SC, Perera MTPR, Mirza DF. Discarded livers tested by normothermic machine perfusion in the VITTAL trial: Secondary end points and 5-year outcomes. Liver Transpl. 2024 Jan 1;30(1):30-45. doi: 10.1097/LVT.0000000000000270. Epub 2023 Dec 15.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Darius Mirza principal investigator
University Hospital Birmingham NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OrganOx metra in people with Liver Transplantation, run by University of Birmingham at 1 site in United Kingdom.
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 14 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 11 Mar 2022. 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient survival (time frame: 90 days). 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 NCT02740608, which also lists 7 linked publications.
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 11 Mar 2022.