Liver DiseasesNCT03837197
Clinical Trial of New Hypothermic Oxygenated Perfusion System Versus Static Cold Storage
A study testing Kidney-Hypothermic oxygenated and Liver-Hypothermic oxygenated in people with Liver Diseases and Kidney Diseases, run by University of Bologna at 1 site in Italy.
Trial summary
With the present study the investigators will evaluate the benefit of end-ischemic HOPE on ECD grafts (livers and kidneys) as compared to SCS. Organs will be perfused through a recently developed machine perfusion (MP) device, from the beginning of back-table procedures till implantation, without increasing CIT. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Liver Diseases, Kidney Diseases
- What is being tested?
- Kidney-Hypothermic oxygenated and Liver-Hypothermic oxygenated
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 21 Dec 2018to Dec 2021
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For kidneys: donor age ≥ 60 years or 50-59 years with two or more of the sequent risk factors: death due to cerebrovascular accident, history of hypertension, donor serum creatinine > 1.5 mg/dL, cold ischemia time (CIT) > 20 h;
- For livers: donors with hemodynamic deterioration, donor age > 65 years, donor body mass index > 30 kg/m2, serum bilirubin > 3 mg/dl, AST or ALT above three times the upper reference threshold, sodium > 165 mmol/l, intensive care unit (ICU) stay > 7 days, steatosis > 40%, CIT > 12 h.
Who cannot join
- Donor age ≤18 years;
- Donors after circulatory death (DCD) will be excluded, because Italian law requires 20 minutes of "no touch period" before death declaration, causing prolonged warm ischemia and subsequent mandatory perfusion of the organ.
- Split-liver recipients, liver transplantation (LT) for acute liver failure, pre-emptive renal transplant, dual kidney transplantation, and patients with intra-operative surgical complications before the organ implantation.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi
Bologna, 40138
Matteo Ravaioli, PhD, 0512144810, mrava1@hotmail.com
Matteo Ravaioli, PhD
About this study
Official title: Expanded Criteria Donors in Liver and Kidney Transplantation: Protocol of a Randomised Single Center Clinical Trial of Hypothermic Oxygenated Perfusion Versus Static Cold Storage
With the present study the investigators will evaluate the benefit of end-ischemic HOPE on ECD grafts (livers and kidneys) as compared to SCS. Organs will be perfused through a recently developed machine perfusion (MP) device, from the beginning of back-table procedures till implantation, without increasing CIT. The aim of the study will be demonstrating the ability of HOPE to improve graft function and post-operative outcomes of ECD kidney and liver recipients.
Read the detailed description
Extended criteria donors (ECD) are widely utilized due to organ shortage, but this may increase the risk of graft dysfunction and of poorer outcomes.
Hypothermic oxygenated perfusion (HOPE) is a recent organ preservation strategy for marginal kidney and liver grafts, which allows to redirect anaerobic metabolism to aerobic metabolism under hypothermic conditions and to protect grafts from oxidative species-related damage; these mechanisms may potentially improve graft function and survival.
Methods This is an open-label, randomized multicenter clinical trial with the aim of comparing HOPE vs. static cold storage (SCS) in ECD kidney and liver transplantation.
In the study protocol - approved by ethics committee - 220 patients (110 liver recipients and 110 kidney recipients) will be enrolled. Livers and kidneys assigned to HOPE will be perfused by machine perfusion with cold Belzer solution (4°-10°C) and with continuous oxygenation (partial pressure of oxygen = 500-600 mmHg). In the control group, livers and kidneys undergoing SCS will be steeped in Celsior or University of Wisconsin Belzer solutions and stored in ice. Using the same perfusion machine for both liver and kidney grafts, organs will be perfused from the start of the back-table procedure until implantation, without increasing cold ischemia time (CIT). For each group the investigators will evaluate clinical outcomes, graft function tests and histologic findings, as well as perfusate and the number of allocated organs.
- Conditions
- Liver Diseases, Kidney Diseases
- Being tested
- Kidney-Hypothermic oxygenated, Liver-Hypothermic oxygenated
- Keywords
- donors and donation, Extended criteria donor, Organ perfusion and preservation, Liver transplantation, Kidney transplantation, Preservation injury, Ischemia reperfusion injury
- Medical subject headings
- Liver Diseases, Kidney Diseases, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney-Hypothermic oxygenatedDevice
Kidney perfusion will be performed through the renal artery at 25-30 mmHg pressure.
Flow, pressure and temperature will be monitored and registered on a Universal Serial Bus (USB) memory system during organ perfusion. Gas analysis of the effluent perfusate will be accomplished at the start of perfusion (T0) then every 30 minutes. Two perfusate samples will be collected at the beginning and at the end of perfusion to rule out bacterial or fungal contamination.
HOPE will start by flushing the organ at low flow values (20 ml/min) with new oxygenated perfusion fluid during back-table preparation. Organ will be treated with continuous HOPE until transplant. Organ perfusion will be continuously monitored. Minimal perfusion time will be 2 hours for kidneys.
Liver-Hypothermic oxygenatedDevice
Liver perfusion will be performed through the portal vein at a 5 mmHg pressure.
Flow, pressure and temperature will be monitored and registered on a Universal Serial Bus (USB) memory system during organ perfusion. Gas analysis of the effluent perfusate will be accomplished at the start of perfusion (T0) then every 30 minutes. Two perfusate samples will be collected at the beginning and at the end of perfusion to rule out bacterial or fungal contamination.
HOPE will start by flushing the organ at low flow values (30 ml/min) with new oxygenated perfusion fluid during back-table preparation. Organ will be treated with continuous HOPE until transplant. Organ perfusion will be continuously monitored. Minimal perfusion time will be 1 hour for livers.
| Study group | Role | What they receive |
|---|---|---|
| Kidney-Hypothermic oxygenated | Experimental | Belzer machine perfusion solution at 4°C-10°C in sterile conditions and continuous oxygenation (partial pressure of oxygen=500-600 mmHg) will be used for perfusion 2000 ml for kidneys. Receives: Device: Kidney-Hypothermic oxygenated |
| Kidney-Static Cold Storage | No intervention | Kidneys undergoing SCS will be stored in sterile organ bags with Celsior or University of Wisconsin solution and cooled in ice. |
| Liver-Hypothermic oxygenated | Experimental | Belzer machine perfusion solution at 4°C-10°C in sterile conditions and continuous oxygenation (partial pressure of oxygen=500-600 mmHg) will be used for perfusion 3000 ml for livers. Receives: Device: Liver-Hypothermic oxygenated |
| Liver-Static Cold Storage | No intervention | Livers undergoing SCS will be stored in sterile organ bags with Celsior or University of Wisconsin solution and cooled in ice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Transplant - Early allograft dysfunction (EAD)
Present/Non present
Measured: 0-30 days after procedure
Kidney Transplant- Delayed graft function (DGF)
Present/Non present
Measured: 0-30 days after procedure
Secondary outcomes (3)
Liver and Kidney surgical complications
Present/Non present
Measured: 0-6 months after procedure
Liver and Kidney graft function at 6 and 12 months
Functioning/non functioning
Measured: 0-12 months after procedure
Patient survival at 6 and 12 months
Alive/Death
Measured: 0-12 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start21 Dec 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Ravaioli, MD, University of Bologna
- Investigators
- Matteo Ravaioli, PhD, Principal investigator, University of Bologna S.Orsola-Malpighi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837197
- Sponsor's protocol ID
- RF-2016-02364732
- Status last verified
- Sep 2019
- First submitted
- 5 Feb 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Belzer FO, Southard JH. Principles of solid-organ preservation by cold storage. Transplantation. 1988 Apr;45(4):673-6. doi: 10.1097/00007890-198804000-00001. No abstract available.
PubMed 3282347Tanrisev M, Hoscoskun C, Asci G, Sozbilen M, Firat O, Ertilav M, Ozkahya M, Toz H. Long-term outcome of kidney transplantation from elderly living and expanded criteria deceased donors. Ren Fail. 2015 Mar;37(2):249-53. doi: 10.3109/0886022X.2014.982488. Epub 2014 Dec 3.
PubMed 25470081Feng S, Goodrich NP, Bragg-Gresham JL, Dykstra DM, Punch JD, DebRoy MA, Greenstein SM, Merion RM. Characteristics associated with liver graft failure: the concept of a donor risk index. Am J Transplant. 2006 Apr;6(4):783-90. doi: 10.1111/j.1600-6143.2006.01242.x.
PubMed 16539636Ravaioli M, Baldassare M, Vasuri F, Pasquinelli G, Laggetta M, Valente S, De Pace V, Neri F, Siniscalchi A, Zanfi C, Bertuzzo VR, Caraceni P, Trere D, Longobardi P, Pinna AD. Strategies to Restore Adenosine Triphosphate (ATP) Level After More than 20 Hours of Cold Ischemia Time in Human Marginal Kidney Grafts. Ann Transplant. 2018 Jan 12;23:34-44. doi: 10.12659/aot.905406.
PubMed 29326416Ravaioli M, De Pace V, Comai G, Busutti M, Del Gaudio M, Amaduzzi A, Cucchetti A, Siniscalchi A, La Manna G, D'Errico AAD, Pinna AD. Successful Dual Kidney Transplantation After Hypothermic Oxygenated Perfusion of Discarded Human Kidneys. Am J Case Rep. 2017 Sep 20;18:1009-1013. doi: 10.12659/ajcr.905377.
PubMed 28928357Kron P, Schlegel A, de Rougemont O, Oberkofler CE, Clavien PA, Dutkowski P. Short, Cool, and Well Oxygenated - HOPE for Kidney Transplantation in a Rodent Model. Ann Surg. 2016 Nov;264(5):815-822. doi: 10.1097/SLA.0000000000001766.
PubMed 27584571Schlegel A, Muller X, Dutkowski P. Hypothermic Machine Preservation of the Liver: State of the Art. Curr Transplant Rep. 2018;5(1):93-102. doi: 10.1007/s40472-018-0183-z. Epub 2018 Jan 22.
PubMed 29564206Dutkowski P, Polak WG, Muiesan P, Schlegel A, Verhoeven CJ, Scalera I, DeOliveira ML, Kron P, Clavien PA. First Comparison of Hypothermic Oxygenated PErfusion Versus Static Cold Storage of Human Donation After Cardiac Death Liver Transplants: An International-matched Case Analysis. Ann Surg. 2015 Nov;262(5):764-70; discussion 770-1. doi: 10.1097/SLA.0000000000001473.
PubMed 26583664Port FK, Bragg-Gresham JL, Metzger RA, Dykstra DM, Gillespie BW, Young EW, Delmonico FL, Wynn JJ, Merion RM, Wolfe RA, Held PJ. Donor characteristics associated with reduced graft survival: an approach to expanding the pool of kidney donors. Transplantation. 2002 Nov 15;74(9):1281-6. doi: 10.1097/00007890-200211150-00014.
PubMed 12451266Attia M, Silva MA, Mirza DF. The marginal liver donor--an update. Transpl Int. 2008 Aug;21(8):713-24. doi: 10.1111/j.1432-2277.2008.00696.x. Epub 2008 May 19.
PubMed 18492121Ravaioli M, De Pace V, Comai G, Capelli I, Baraldi O, D'Errico A, Bertuzzo VR, Del Gaudio M, Zanfi C, D'Arcangelo GL, Cuna V, Siniscalchi A, Sangiorgi G, La Manna G. Preliminary experience of sequential use of normothermic and hypothermic oxygenated perfusion for donation after circulatory death kidney with warm ischemia time over the conventional criteria - a retrospective and observational study. Transpl Int. 2018 Nov;31(11):1233-1244. doi: 10.1111/tri.13311. Epub 2018 Jul 20.
PubMed 29957863Olthoff KM, Kulik L, Samstein B, Kaminski M, Abecassis M, Emond J, Shaked A, Christie JD. Validation of a current definition of early allograft dysfunction in liver transplant recipients and analysis of risk factors. Liver Transpl. 2010 Aug;16(8):943-9. doi: 10.1002/lt.22091.
PubMed 20677285Agopian VG, Harlander-Locke MP, Markovic D, Dumronggittigule W, Xia V, Kaldas FM, Zarrinpar A, Yersiz H, Farmer DG, Hiatt JR, Busuttil RW. Evaluation of Early Allograft Function Using the Liver Graft Assessment Following Transplantation Risk Score Model. JAMA Surg. 2018 May 1;153(5):436-444. doi: 10.1001/jamasurg.2017.5040.
PubMed 29261831Humar A, Ramcharan T, Kandaswamy R, Gillingham K, Payne WD, Matas AJ. Risk factors for slow graft function after kidney transplants: a multivariate analysis. Clin Transplant. 2002 Dec;16(6):425-9. doi: 10.1034/j.1399-0012.2002.02055.x.
PubMed 12437622Schlegel A, de Rougemont O, Graf R, Clavien PA, Dutkowski P. Protective mechanisms of end-ischemic cold machine perfusion in DCD liver grafts. J Hepatol. 2013 Feb;58(2):278-86. doi: 10.1016/j.jhep.2012.10.004. Epub 2012 Oct 11.
PubMed 23063573
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Criteria Donors in Liver and Kidney Transplantation: Protocol of a Randomised Single Center Clinical Trial of Hypothermic Oxygenated Perfusion Versus Static Cold Storage
- ClinicalTrials.gov ID
- NCT03837197
- Acronym / sponsor ID
- RF-2016-02364732
- Conditions
- Liver Diseases, Kidney Diseases
- Keywords
- donors and donation, Extended criteria donor, Organ perfusion and preservation, Liver transplantation, Kidney transplantation, Preservation injury, Ischemia reperfusion injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 12 Feb 2019 (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.
With the present study the investigators will evaluate the benefit of end-ischemic HOPE on ECD grafts (livers and kidneys) as compared to SCS. Organs will be perfused through a recently developed machine perfusion (MP) device, from the beginning of back-table procedures till implantation, without increasing CIT. The aim of the study will be demonstrating the ability of HOPE to improve graft function and post-operative outcomes of ECD kidney and liver recipients.
Detailed description
Extended criteria donors (ECD) are widely utilized due to organ shortage, but this may increase the risk of graft dysfunction and of poorer outcomes.
Hypothermic oxygenated perfusion (HOPE) is a recent organ preservation strategy for marginal kidney and liver grafts, which allows to redirect anaerobic metabolism to aerobic metabolism under hypothermic conditions and to protect grafts from oxidative species-related damage; these mechanisms may potentially improve graft function and survival.
Methods This is an open-label, randomized multicenter clinical trial with the aim of comparing HOPE vs. static cold storage (SCS) in ECD kidney and liver transplantation.
In the study protocol - approved by ethics committee - 220 patients (110 liver recipients and 110 kidney recipients) will be enrolled. Livers and kidneys assigned to HOPE will be perfused by machine perfusion with cold Belzer solution (4°-10°C) and with continuous oxygenation (partial pressure of oxygen = 500-600 mmHg). In the control group, livers and kidneys undergoing SCS will be steeped in Celsior or University of Wisconsin Belzer solutions and stored in ice. Using the same perfusion machine for both liver and kidney grafts, organs will be perfused from the start of the back-table procedure until implantation, without increasing cold ischemia time (CIT). For each group the investigators will evaluate clinical outcomes, graft function tests and histologic findings, as well as perfusate and the number of allocated organs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Kidney-Hypothermic oxygenated | Experimental | Device: Kidney-Hypothermic oxygenatedBelzer machine perfusion solution at 4°C-10°C in sterile conditions and continuous oxygenation (partial pressure of oxygen=500-600 mmHg) will be used for perfusion 2000 ml for kidneys. |
| Kidney-Static Cold Storage | No intervention | –Kidneys undergoing SCS will be stored in sterile organ bags with Celsior or University of Wisconsin solution and cooled in ice. |
| Liver-Hypothermic oxygenated | Experimental | Device: Liver-Hypothermic oxygenatedBelzer machine perfusion solution at 4°C-10°C in sterile conditions and continuous oxygenation (partial pressure of oxygen=500-600 mmHg) will be used for perfusion 3000 ml for livers. |
| Liver-Static Cold Storage | No intervention | –Livers undergoing SCS will be stored in sterile organ bags with Celsior or University of Wisconsin solution and cooled in ice. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For kidneys: donor age ≥ 60 years or 50-59 years with two or more of the sequent risk factors: death due to cerebrovascular accident, history of hypertension, donor serum creatinine > 1.5 mg/dL, cold ischemia time (CIT) > 20 h;
- For livers: donors with hemodynamic deterioration, donor age > 65 years, donor body mass index > 30 kg/m2, serum bilirubin > 3 mg/dl, AST or ALT above three times the upper reference threshold, sodium > 165 mmol/l, intensive care unit (ICU) stay > 7 days, steatosis > 40%, CIT > 12 h.
Key exclusion criteria (3 listed)
- Donor age ≤18 years;
- Donors after circulatory death (DCD) will be excluded, because Italian law requires 20 minutes of "no touch period" before death declaration, causing prolonged warm ischemia and subsequent mandatory perfusion of the organ.
- Split-liver recipients, liver transplantation (LT) for acute liver failure, pre-emptive renal transplant, dual kidney transplantation, and patients with intra-operative surgical complications before the organ implantation.
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 |
|---|---|---|
| Kidney-Hypothermic oxygenatedKidney perfusion will be performed through the renal artery at 25-30 mmHg pressure. Flow, pressure and temperature will be monitored and registered on a Universal Serial Bus (USB) memory system during organ perfusion. Gas analysis of the effluent perfusate will be accomplished at the start of perfusion (T0) then every 30 minutes. Two perfusate samples will be collected at the beginning and at the end of perfusion to rule out bacterial or fungal contamination. HOPE will start by flushing the organ at low flow values (20 ml/min) with new oxygenated perfusion fluid during back-table preparation. Organ will be treated with continuous HOPE until transplant. Organ perfusion will be continuously monitored. Minimal perfusion time will be 2 hours for kidneys. | Device | Kidney-Hypothermic oxygenated |
| Liver-Hypothermic oxygenatedLiver perfusion will be performed through the portal vein at a 5 mmHg pressure. Flow, pressure and temperature will be monitored and registered on a Universal Serial Bus (USB) memory system during organ perfusion. Gas analysis of the effluent perfusate will be accomplished at the start of perfusion (T0) then every 30 minutes. Two perfusate samples will be collected at the beginning and at the end of perfusion to rule out bacterial or fungal contamination. HOPE will start by flushing the organ at low flow values (30 ml/min) with new oxygenated perfusion fluid during back-table preparation. Organ will be treated with continuous HOPE until transplant. Organ perfusion will be continuously monitored. Minimal perfusion time will be 1 hour for livers. | Device | Liver-Hypothermic oxygenated |
Primary outcome
Liver Transplant - Early allograft dysfunction (EAD)
Time frame: 0-30 days after procedure
Present/Non present
Kidney Transplant- Delayed graft function (DGF)
Time frame: 0-30 days after procedure
Present/Non present
3 secondary outcomes
Liver and Kidney surgical complications
Time frame: 0-6 months after procedure
Liver and Kidney graft function at 6 and 12 months
Time frame: 0-12 months after procedure
Patient survival at 6 and 12 months
Time frame: 0-12 months after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Background: PubMed 3282347Belzer FO, Southard JH. Principles of solid-organ preservation by cold storage. Transplantation. 1988 Apr;45(4):673-6. doi: 10.1097/00007890-198804000-00001. No abstract available.
- Background: PubMed 25470081Tanrisev M, Hoscoskun C, Asci G, Sozbilen M, Firat O, Ertilav M, Ozkahya M, Toz H. Long-term outcome of kidney transplantation from elderly living and expanded criteria deceased donors. Ren Fail. 2015 Mar;37(2):249-53. doi: 10.3109/0886022X.2014.982488. Epub 2014 Dec 3.
- Background: PubMed 16539636Feng S, Goodrich NP, Bragg-Gresham JL, Dykstra DM, Punch JD, DebRoy MA, Greenstein SM, Merion RM. Characteristics associated with liver graft failure: the concept of a donor risk index. Am J Transplant. 2006 Apr;6(4):783-90. doi: 10.1111/j.1600-6143.2006.01242.x.
- Background: PubMed 29326416Ravaioli M, Baldassare M, Vasuri F, Pasquinelli G, Laggetta M, Valente S, De Pace V, Neri F, Siniscalchi A, Zanfi C, Bertuzzo VR, Caraceni P, Trere D, Longobardi P, Pinna AD. Strategies to Restore Adenosine Triphosphate (ATP) Level After More than 20 Hours of Cold Ischemia Time in Human Marginal Kidney Grafts. Ann Transplant. 2018 Jan 12;23:34-44. doi: 10.12659/aot.905406.
- Background: PubMed 28928357Ravaioli M, De Pace V, Comai G, Busutti M, Del Gaudio M, Amaduzzi A, Cucchetti A, Siniscalchi A, La Manna G, D'Errico AAD, Pinna AD. Successful Dual Kidney Transplantation After Hypothermic Oxygenated Perfusion of Discarded Human Kidneys. Am J Case Rep. 2017 Sep 20;18:1009-1013. doi: 10.12659/ajcr.905377.
- Background: PubMed 27584571Kron P, Schlegel A, de Rougemont O, Oberkofler CE, Clavien PA, Dutkowski P. Short, Cool, and Well Oxygenated - HOPE for Kidney Transplantation in a Rodent Model. Ann Surg. 2016 Nov;264(5):815-822. doi: 10.1097/SLA.0000000000001766.
- Background: PubMed 29564206Schlegel A, Muller X, Dutkowski P. Hypothermic Machine Preservation of the Liver: State of the Art. Curr Transplant Rep. 2018;5(1):93-102. doi: 10.1007/s40472-018-0183-z. Epub 2018 Jan 22.
- Background: PubMed 26583664Dutkowski P, Polak WG, Muiesan P, Schlegel A, Verhoeven CJ, Scalera I, DeOliveira ML, Kron P, Clavien PA. First Comparison of Hypothermic Oxygenated PErfusion Versus Static Cold Storage of Human Donation After Cardiac Death Liver Transplants: An International-matched Case Analysis. Ann Surg. 2015 Nov;262(5):764-70; discussion 770-1. doi: 10.1097/SLA.0000000000001473.
- Background: PubMed 12451266Port FK, Bragg-Gresham JL, Metzger RA, Dykstra DM, Gillespie BW, Young EW, Delmonico FL, Wynn JJ, Merion RM, Wolfe RA, Held PJ. Donor characteristics associated with reduced graft survival: an approach to expanding the pool of kidney donors. Transplantation. 2002 Nov 15;74(9):1281-6. doi: 10.1097/00007890-200211150-00014.
- Background: PubMed 18492121Attia M, Silva MA, Mirza DF. The marginal liver donor--an update. Transpl Int. 2008 Aug;21(8):713-24. doi: 10.1111/j.1432-2277.2008.00696.x. Epub 2008 May 19.
- Background: PubMed 29957863Ravaioli M, De Pace V, Comai G, Capelli I, Baraldi O, D'Errico A, Bertuzzo VR, Del Gaudio M, Zanfi C, D'Arcangelo GL, Cuna V, Siniscalchi A, Sangiorgi G, La Manna G. Preliminary experience of sequential use of normothermic and hypothermic oxygenated perfusion for donation after circulatory death kidney with warm ischemia time over the conventional criteria - a retrospective and observational study. Transpl Int. 2018 Nov;31(11):1233-1244. doi: 10.1111/tri.13311. Epub 2018 Jul 20.
- Background: PubMed 20677285Olthoff KM, Kulik L, Samstein B, Kaminski M, Abecassis M, Emond J, Shaked A, Christie JD. Validation of a current definition of early allograft dysfunction in liver transplant recipients and analysis of risk factors. Liver Transpl. 2010 Aug;16(8):943-9. doi: 10.1002/lt.22091.
- Sistema Informativo Trapianti (SIT)Link provided by the sponsor.
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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.
Matteo Ravaioli, PhD principal investigator
University of Bologna S.Orsola-Malpighi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kidney-Hypothermic oxygenated and Liver-Hypothermic oxygenated in people with Liver Diseases and Kidney Diseases, run by University of Bologna at 1 site in Italy.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Sep 2019. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matteo Ravaioli, PhD (0512144810 ext. +39, mrava1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Transplant - Early allograft dysfunction (EAD) (time frame: 0-30 days after procedure). 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 NCT03837197, which also lists 19 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 27 Sep 2019.