Liver TransplantORGANOXLAFENCT03930459
Efficacy of Ex-situ Normothermic Perfusion Versus Cold Storage in the Transplant With Steatotic Liver Graft.
A study testing Static cold storage (SCS) and Normothermic machine perfusion (NMP) in people with Liver Transplant, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
Trial summary
Prospective, randomized, controlled clinical trial to determine the overall efficacy of normothermic machine perfusion (NMP) for steatotic liver preservation versus traditional static cold storage (SCS), in 50 liver transplant recipients with 1-year follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Static cold storage (SCS) and Normothermic machine perfusion (NMP)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSpain
- Study dates
- 26 Apr 2019to 4 Apr 2023
- 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 DONOR:
- Donors older than 16 years
- Liver donation grafts due to brain death
- Steatosis confirmed by histological study (between 30% and 60% of macrovesicular steatosis)
- LIVER RECIPIENT:
- Adult patients (18 years or older)
- Active liver transplant waiting list candidate
- Able to give informed consent
Who cannot join
- LIVER DONOR:
- Living donors
- Liver destined to the transplant "split"
- Donor age <16 years
- Donation after death due to asystole.
- When the biopsy establishes a steatosis ≥ 50%, patients who fulfill at least 3 of the following 5 risk factors will be excluded: Transaminases (AST and ALT) ≥ 200 U / L; Age ≥ 55 years; Hypernatremia ≥ 155 mEq / L; Cardiovascular risk factors, at least 2 of the following 5: DM, HTA, IMC ≥ 35, Active smoking, ischemic stroke; Days of stay in ICU ≥ 4 days with vasoactive drugs (noradrenaline or dobutamine at any dose)
Show all 12Show fewer
- LIVER RECIPIENT:
- Age under 18
- Acute/fulminant hepatic failure
- Transplant of more than one organ (for example, liver and kidney)
- Rejection of informed consent
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Compare the Efficacy of Ex-situ Normothermic Perfusion With Cold Storage in the Transplant With Steatotic Liver Graft.
Prospective, randomized, controlled clinical trial to determine the overall efficacy of normothermic machine perfusion (NMP) for steatotic liver preservation versus traditional static cold storage (SCS), in 50 liver transplant recipients with 1-year follow-up.
Read the detailed description
This is a prospective, randomized, controlled clinical trial comparing static cold storage (SCS) versus normothermic machine perfusion (NMP) for organ preservation before liver transplantation with steatotic livers (between 30 % and 60% of histologic macrovesicular steatosis), in order to:
Main Objective:
To compare the effect of NMP versus SCS in preventing preservation injury and graft dysfunction, as measured by highest transaminase levels during the first week after liver transplantation.
Secondary Objectives:
- To compare graft and patient survival between the NMP and SCS steatotic livers.
- To compare the liver biochemical function between the NMP and SCS steatotic livers.
- To compare the physiological response to the reperfusion between the NMP and SCS steatotic livers.
- To compare the evidence of reperfusion injury between the NMP and SCS steatotic livers.
- To compare the evidence of ischemic cholangiopathy between the NMP and SCS steatotic livers.
- Conditions
- Liver Transplant
- Being tested
- Static cold storage (SCS), Normothermic machine perfusion (NMP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static cold storage (SCS)Procedure or surgery
The liver is flushed and cooled with specialist preservation fluid, then stored in an icebox.
Normothermic machine perfusion (NMP)Device
During NMP, the liver is perfused with oxygenated blood, medications and nutrients at normal body temperature to maintain a physiological milieu.
| Study group | Role | What they receive |
|---|---|---|
| Static cold storage (SCS) | Experimental | Traditional method of organ preservation which involves flushing of cold preservation solution following complete dissection and interruption of blood supply to the donor organ. Although cold preservation slows metabolism by 10- to 12-fold, substantial anaerobic activity continues even at ice temperature. This lead to the generation of reactive oxygen species that are the basis of ischaemia-reperfusion injury, when the organ is re-exposed to oxygenated blood at the time of transplantation. This damage, exacerbated by any prior injury, limits the maximum safe preservation time of the donor organ. Receives: Procedure: Static cold storage (SCS) |
| Normothermic machine perfusion (NMP) | Experimental | The main goal of NMP is to optimize graft preservation by mimicking physiological conditions. The perfused organ is supplied with nutrients and oxygen to maintain metabolic hemostasis. Under these conditions, ATP and glycogen reserves can be maintained or actively restored. At the same time, toxic products from the cellular milieu are continuously eliminated, so the cell-mediated injury phase of reperfusion injury can be minimized. Thus, ischemic injury is avoided and the activation of cell death cascades is prevented. This allows both hepatocellular and biliary protection. Receives: Device: Normothermic machine perfusion (NMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak of transaminases (AST and ALT)
Measured: Day 1 post-transplant.
Peak of transaminases (AST and ALT)
Measured: Day 3 post-transplant.
Peak of transaminases (AST and ALT)
Measured: Day 5 post-transplant.
Peak of transaminases (AST and ALT) l
Measured: Day 7 post-transplant.
Secondary outcomes (16)
Primary graft failure
Primary graft failure: irreversible graft dysfunction that requires emergency hepatic replacement during the first 10 days after liver transplantation, in the absence of technical or immunological causes.
Measured: Day 10 post-transplant.
Graft survival
Measured: Day 30 post-transplant, month 6 post-transplant, month 12 post-transplant.
Patient survival
Measured: Day 30 post-transplant, month 6 post-transplant, month 12 post-transplant.
Post-reperfusion syndrome, measured by mean arterial pressure (MAP) levels
Post-reperfusion syndrome is defined as a decrease in mean arterial pressure (MAP) of more than 30% of the baseline value for more than one minute during the first five minutes after reperfusion. This will be evaluated in the context of the use of vasopressors.
Measured: During the first 5 minutes after reperfusion
Biochemical function of the liver measured by Bilirubin post-transplant levels
Measured: Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant
Biochemical function of the liver measured by GGT post-transplant levels
Measured: Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant
Biochemical function of the liver measured by AST post-transplant levels
Measured: Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant
Biochemical function of the liver measured by ALT post-transplant levels
Measured: Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant
Biochemical function of the liver measured by INR post-transplant levels
Measured: Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant
Early graft dysfunction
Defined by:
- Bilirubin > 10 mg / dl daily 7 after transplant
- INR > 1.6 on day 7 after transplantation.
- Peak AST and ALT > 2000 IU / L in the first 7 days after transplantation
Measured: 7 days post-transplant
Intensive care stay duration
Measured: Day 30
Hospital stay duration
Measured: Day 30
Renal replacement therapy need
Measured: Day 30, month 6, month 12 post- transplant
Intraoperative thromboelastogram result
Measured: In transplant surgery
Histological evidence of reperfusion injury
Post-reperfusion biopsies will be compared with baseline pre-reperfusion biopsies and classified according to standard histological criteria (blind comparison to third parties).
Measured: In transplant surgery
Evidence of biliary stenosis in magnetic resonance cholangiography (MRS).
Measured: 6 months after transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start26 Apr 2019
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930459
- Sponsor's protocol ID
- ORGANOXLAFE
- Acronym
- ORGANOXLAFE
- Status last verified
- Aug 2019
- First submitted
- 23 Apr 2019
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garcia-Valdecasas JC, Tabet J, Valero R, Taura P, Rull R, Garcia F, Montserrat E, Gonzalez FX, Ordi J, Beltran J, Lopez-Boado MA, Deulofeu R, Angas J, Cifuentes A, Visa J. Liver conditioning after cardiac arrest: the use of normothermic recirculation in an experimental animal model. Transpl Int. 1998;11(6):424-32. doi: 10.1007/s001470050169.
PubMed 9870271St Peter SD, Imber CJ, Lopez I, Hughes D, Friend PJ. Extended preservation of non-heart-beating donor livers with normothermic machine perfusion. Br J Surg. 2002 May;89(5):609-16. doi: 10.1046/j.1365-2168.2002.02052.x.
PubMed 11972552Imber CJ, St Peter SD, Lopez de Cenarruzabeitia I, Pigott D, James T, Taylor R, McGuire J, Hughes D, Butler A, Rees M, Friend PJ. Advantages of normothermic perfusion over cold storage in liver preservation. Transplantation. 2002 Mar 15;73(5):701-9. doi: 10.1097/00007890-200203150-00008.
PubMed 11907414Gaffey MJ, Boyd JC, Traweek ST, Ali MA, Rezeig M, Caldwell SH, Iezzoni JC, McCullough C, Stevenson WC, Khuroo S, Nezamuddin N, Ishitani MB, Pruett TL. Predictive value of intraoperative biopsies and liver function tests for preservation injury in orthotopic liver transplantation. Hepatology. 1997 Jan;25(1):184-9. doi: 10.1002/hep.510250134.
PubMed 8985288Karayalcin K, Mirza DF, Harrison RF, Da Silva RF, Hubscher SG, Mayer AD, Buckels JA, McMaster P. The role of dynamic and morphological studies in the assessment of potential liver donors. Transplantation. 1994 May 15;57(9):1323-7. doi: 10.1097/00007890-199405150-00006.
PubMed 8184469Abraham S, Furth EE. Quantitative evaluation of histological features in "time-zero" liver allograft biopsies as predictors of rejection or graft failure: receiver-operating characteristic analysis application. Hum Pathol. 1996 Oct;27(10):1077-84. doi: 10.1016/s0046-8177(96)90287-7.
PubMed 8892594Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Olthoff 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 20677285Chung IS, Kim HY, Shin YH, Ko JS, Gwak MS, Sim WS, Kim GS, Lee SK. Incidence and predictors of post-reperfusion syndrome in living donor liver transplantation. Clin Transplant. 2012 Jul-Aug;26(4):539-43. doi: 10.1111/j.1399-0012.2011.01568.x. Epub 2011 Dec 14.
PubMed 22168355Hilmi I, Horton CN, Planinsic RM, Sakai T, Nicolau-Raducu R, Damian D, Gligor S, Marcos A. The impact of postreperfusion syndrome on short-term patient and liver allograft outcome in patients undergoing orthotopic liver transplantation. Liver Transpl. 2008 Apr;14(4):504-8. doi: 10.1002/lt.21381.
PubMed 18383079Glanemann M, Langrehr JM, Stange BJ, Neumann U, Settmacher U, Steinmuller T, Neuhaus P. Clinical implications of hepatic preservation injury after adult liver transplantation. Am J Transplant. 2003 Aug;3(8):1003-9. doi: 10.1034/j.1600-6143.2003.00167.x.
PubMed 12859537Eisenbach C, Encke J, Merle U, Gotthardt D, Weiss KH, Schneider L, Latanowicz S, Spiegel M, Engelmann G, Stremmel W, Buchler MW, Schmidt J, Weigand MA, Sauer P. An early increase in gamma glutamyltranspeptidase and low aspartate aminotransferase peak values are associated with superior outcomes after orthotopic liver transplantation. Transplant Proc. 2009 Jun;41(5):1727-30. doi: 10.1016/j.transproceed.2009.01.084.
PubMed 19545716Nasralla D, Coussios CC, Mergental H, Akhtar MZ, Butler AJ, Ceresa CDL, Chiocchia V, Dutton SJ, Garcia-Valdecasas JC, Heaton N, Imber C, Jassem W, Jochmans I, Karani J, Knight SR, Kocabayoglu P, Malago M, Mirza D, Morris PJ, Pallan A, Paul A, Pavel M, Perera MTPR, Pirenne J, Ravikumar R, Russell L, Upponi S, Watson CJE, Weissenbacher A, Ploeg RJ, Friend PJ; Consortium for Organ Preservation in Europe. A randomized trial of normothermic preservation in liver transplantation. Nature. 2018 May;557(7703):50-56. doi: 10.1038/s41586-018-0047-9. Epub 2018 Apr 18.
PubMed 29670285
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Compare the Efficacy of Ex-situ Normothermic Perfusion With Cold Storage in the Transplant With Steatotic Liver Graft.
- ClinicalTrials.gov ID
- NCT03930459
- Acronym / sponsor ID
- ORGANOXLAFE / ORGANOXLAFE
- Conditions
- Liver Transplant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 29 Apr 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.
Prospective, randomized, controlled clinical trial to determine the overall efficacy of normothermic machine perfusion (NMP) for steatotic liver preservation versus traditional static cold storage (SCS), in 50 liver transplant recipients with 1-year follow-up.
Detailed description
This is a prospective, randomized, controlled clinical trial comparing static cold storage (SCS) versus normothermic machine perfusion (NMP) for organ preservation before liver transplantation with steatotic livers (between 30 % and 60% of histologic macrovesicular steatosis), in order to:
Main Objective:
To compare the effect of NMP versus SCS in preventing preservation injury and graft dysfunction, as measured by highest transaminase levels during the first week after liver transplantation.
Secondary Objectives:
- To compare graft and patient survival between the NMP and SCS steatotic livers.
- To compare the liver biochemical function between the NMP and SCS steatotic livers.
- To compare the physiological response to the reperfusion between the NMP and SCS steatotic livers.
- To compare the evidence of reperfusion injury between the NMP and SCS steatotic livers.
- To compare the evidence of ischemic cholangiopathy between the NMP and SCS steatotic livers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Static cold storage (SCS) | Experimental | Procedure: Static cold storage (SCS)Traditional method of organ preservation which involves flushing of cold preservation solution following complete dissection and interruption of blood supply to the donor organ. Although cold preservation slows metabolism by 10- to 12-fold, substantial anaerobic activity continues even at ice temperature. This lead to the generation of reactive oxygen species that are the basis of ischaemia-reperfusion injury, when the organ is re-exposed to oxygenated blood at the time of transplantation. This damage, exacerbated by any prior injury, limits the maximum safe preservation time of the donor organ. |
| Normothermic machine perfusion (NMP) | Experimental | Device: Normothermic machine perfusion (NMP)The main goal of NMP is to optimize graft preservation by mimicking physiological conditions. The perfused organ is supplied with nutrients and oxygen to maintain metabolic hemostasis. Under these conditions, ATP and glycogen reserves can be maintained or actively restored. At the same time, toxic products from the cellular milieu are continuously eliminated, so the cell-mediated injury phase of reperfusion injury can be minimized. Thus, ischemic injury is avoided and the activation of cell death cascades is prevented. This allows both hepatocellular and biliary protection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Donors older than 16 years
- Liver donation grafts due to brain death
- Steatosis confirmed by histological study (between 30% and 60% of macrovesicular steatosis)
- Adult patients (18 years or older)
- Active liver transplant waiting list candidate
Key exclusion criteria (12 listed)
- Living donors
- Liver destined to the transplant "split"
- Donor age <16 years
- Donation after death due to asystole.
- When the biopsy establishes a steatosis ≥ 50%, patients who fulfill at least 3 of the following 5 risk factors will be excluded: Transaminases (AST and ALT) ≥ 200 U / L; Age ≥ 55 years; Hypernatremia ≥ 155 mEq / L; Cardiovascular risk factors, at least 2 of the following 5: DM, HTA, IMC ≥ 35, Active smoking, ischemic stroke; Days of stay in ICU ≥ 4 days with vasoactive drugs (noradrenaline or dobutamine at any dose)
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 |
|---|---|---|
| Static cold storage (SCS)The liver is flushed and cooled with specialist preservation fluid, then stored in an icebox. | Procedure or surgery | Static cold storage (SCS) |
| Normothermic machine perfusion (NMP)During NMP, the liver is perfused with oxygenated blood, medications and nutrients at normal body temperature to maintain a physiological milieu. | Device | Normothermic machine perfusion (NMP) |
Primary outcome
Peak of transaminases (AST and ALT)
Time frame: Day 1 post-transplant.
Peak of transaminases (AST and ALT)
Time frame: Day 3 post-transplant.
Peak of transaminases (AST and ALT)
Time frame: Day 5 post-transplant.
Peak of transaminases (AST and ALT) l
Time frame: Day 7 post-transplant.
16 secondary outcomes
Primary graft failure
Time frame: Day 10 post-transplant.
Graft survival
Time frame: Day 30 post-transplant, month 6 post-transplant, month 12 post-transplant.
Patient survival
Time frame: Day 30 post-transplant, month 6 post-transplant, month 12 post-transplant.
Post-reperfusion syndrome, measured by mean arterial pressure (MAP) levels
Time frame: During the first 5 minutes after reperfusion
Biochemical function of the liver measured by Bilirubin post-transplant levels
Time frame: Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant
Biochemical function of the liver measured by GGT post-transplant levels
Time frame: Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant
Biochemical function of the liver measured by AST post-transplant levels
Time frame: Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant
Biochemical function of the liver measured by ALT post-transplant levels
Time frame: Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant
Biochemical function of the liver measured by INR post-transplant levels
Time frame: Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant
Early graft dysfunction
Time frame: 7 days post-transplant
Intensive care stay duration
Time frame: Day 30
Hospital stay duration
Time frame: Day 30
Renal replacement therapy need
Time frame: Day 30, month 6, month 12 post- transplant
Intraoperative thromboelastogram result
Time frame: In transplant surgery
Histological evidence of reperfusion injury
Time frame: In transplant surgery
Evidence of biliary stenosis in magnetic resonance cholangiography (MRS).
Time frame: 6 months after transplantation.
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Background: PubMed 9870271Garcia-Valdecasas JC, Tabet J, Valero R, Taura P, Rull R, Garcia F, Montserrat E, Gonzalez FX, Ordi J, Beltran J, Lopez-Boado MA, Deulofeu R, Angas J, Cifuentes A, Visa J. Liver conditioning after cardiac arrest: the use of normothermic recirculation in an experimental animal model. Transpl Int. 1998;11(6):424-32. doi: 10.1007/s001470050169.
- Background: PubMed 11972552St Peter SD, Imber CJ, Lopez I, Hughes D, Friend PJ. Extended preservation of non-heart-beating donor livers with normothermic machine perfusion. Br J Surg. 2002 May;89(5):609-16. doi: 10.1046/j.1365-2168.2002.02052.x.
- Background: PubMed 11907414Imber CJ, St Peter SD, Lopez de Cenarruzabeitia I, Pigott D, James T, Taylor R, McGuire J, Hughes D, Butler A, Rees M, Friend PJ. Advantages of normothermic perfusion over cold storage in liver preservation. Transplantation. 2002 Mar 15;73(5):701-9. doi: 10.1097/00007890-200203150-00008.
- Background: PubMed 8985288Gaffey MJ, Boyd JC, Traweek ST, Ali MA, Rezeig M, Caldwell SH, Iezzoni JC, McCullough C, Stevenson WC, Khuroo S, Nezamuddin N, Ishitani MB, Pruett TL. Predictive value of intraoperative biopsies and liver function tests for preservation injury in orthotopic liver transplantation. Hepatology. 1997 Jan;25(1):184-9. doi: 10.1002/hep.510250134.
- Background: PubMed 8184469Karayalcin K, Mirza DF, Harrison RF, Da Silva RF, Hubscher SG, Mayer AD, Buckels JA, McMaster P. The role of dynamic and morphological studies in the assessment of potential liver donors. Transplantation. 1994 May 15;57(9):1323-7. doi: 10.1097/00007890-199405150-00006.
- Background: PubMed 8892594Abraham S, Furth EE. Quantitative evaluation of histological features in "time-zero" liver allograft biopsies as predictors of rejection or graft failure: receiver-operating characteristic analysis application. Hum Pathol. 1996 Oct;27(10):1077-84. doi: 10.1016/s0046-8177(96)90287-7.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- 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.
- Background: PubMed 22168355Chung IS, Kim HY, Shin YH, Ko JS, Gwak MS, Sim WS, Kim GS, Lee SK. Incidence and predictors of post-reperfusion syndrome in living donor liver transplantation. Clin Transplant. 2012 Jul-Aug;26(4):539-43. doi: 10.1111/j.1399-0012.2011.01568.x. Epub 2011 Dec 14.
- Background: PubMed 18383079Hilmi I, Horton CN, Planinsic RM, Sakai T, Nicolau-Raducu R, Damian D, Gligor S, Marcos A. The impact of postreperfusion syndrome on short-term patient and liver allograft outcome in patients undergoing orthotopic liver transplantation. Liver Transpl. 2008 Apr;14(4):504-8. doi: 10.1002/lt.21381.
- Background: PubMed 12859537Glanemann M, Langrehr JM, Stange BJ, Neumann U, Settmacher U, Steinmuller T, Neuhaus P. Clinical implications of hepatic preservation injury after adult liver transplantation. Am J Transplant. 2003 Aug;3(8):1003-9. doi: 10.1034/j.1600-6143.2003.00167.x.
- Background: PubMed 19545716Eisenbach C, Encke J, Merle U, Gotthardt D, Weiss KH, Schneider L, Latanowicz S, Spiegel M, Engelmann G, Stremmel W, Buchler MW, Schmidt J, Weigand MA, Sauer P. An early increase in gamma glutamyltranspeptidase and low aspartate aminotransferase peak values are associated with superior outcomes after orthotopic liver transplantation. Transplant Proc. 2009 Jun;41(5):1727-30. doi: 10.1016/j.transproceed.2009.01.084.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static cold storage (SCS) and Normothermic machine perfusion (NMP) in people with Liver Transplant, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 29 Sep 2023. 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 Spain. 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 was stopped early (reason given: low recruitment). Results are not available in the source record.
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?
Peak of transaminases (AST and ALT) (time frame: Day 1 post-transplant.). The study lists 4 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 NCT03930459, which also lists 13 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 29 Sep 2023.