search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


A single center Phase-I Clinical Trial to Assess Viability of High Risk Donor Livers using Normothermic Machine Perfusion Prior to Transplantation


- candidate number24659
- NTR NumberNTR5972
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jul-2016
- Secondary IDs201600417 
- Public TitleA single center Phase-I Clinical Trial to Assess Viability of High Risk Donor Livers using Normothermic Machine Perfusion Prior to Transplantation
- Scientific TitleA single center Phase-I Clinical Trial to Assess Viability of High Risk Donor Livers using Normothermic Machine Perfusion Prior to Transplantation
- ACRONYM
- hypothesis1.Potentially transplantable high risk donor liver grafts can be distinguished from non-viable high risk donor liver grafts using NMP.
2.DHOPE, prior to ex situ viability assessment, increases the odds of a high risk donor liver graft to be accepted for transplantation.
- Healt Condition(s) or Problem(s) studiedLiver transplantation
- Inclusion criteriaRecipient
-Adult patients (≥ 18 years old)
-Given informed consent

Donor grafts
-Donors with a body weight ≥40 kg
- Exclusion criteriaRecipient
-Simultaneous participation in another clinical trial that might possibly influence this trial
-Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial
-Listed for liver transplantation due to fulminant liver failure or retransplantation because of PNF
-Recipient tested positive for HIV

Donor grafts
-Donor tested positive for HIV, Hepatitis B or C
-Split or partial liver grafts
-Domino donor livers
-Expected cold ischemia time of ≥ 10 hours (4)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-sep-2016
- planned closingdate1-sep-2017
- Target number of participants10
- InterventionsEach high risk donor liver accepted for this study will undergo machine perfusion. First, DHOPE will take place, before gradually rewarming the donor liver to a normothermic temperature. Secondly, after rewarming, NMP will be performed to allow graft assessment.
- Primary outcomeThe primary endpoint is graft survival at 3 months after transplantation.
- Secondary outcome-Graft and patient survival at 7 days and 1 month.
-Primary non-function (PNF): Occurrence of retransplantation or patient death within the first 7 days after OLT, without any identifiable cause of graft dysfunction 12.
-Early allograft dysfunction (EAD), presence of one or more of the following variables 13:
-Elevation of AST and/or ALT above a defined cut-off value (>2000 IU/mL ) within the first 7 days after OLT;
-Elevated international normalized ratio (INR) of ≥1.6 on day 7 after OLT;
-Elevated bilirubin levels of ≥10 mg/dL on day 7 after OLT.
-Development of non-anastomotic biliary strictures (NAS).
-Biochemical analysis of graft function and ischemia-reperfusion injury determined with serum levels of ALT, AST, AlkP, γGT, INR and total bilirubin at postoperative day 0-7 and 1 and 3 months.
- TimepointsAs described in boxes primary outcome(s) and secondary outcome(s)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Y. de Vries
- CONTACT for SCIENTIFIC QUERIES Y. de Vries
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG), Tekke Huizinga Fonds
- Publications
- Brief summaryCurrently, there is a shortage of suitable donor livers. To expand the donor pool, livers from high risk donors, termed extended criteria donor (ECD) livers are increasingly accepted for transplantation. To counter the increased risk of developing severe complications, such as primary non function (PNF), machine perfusion can be used to evaluate and improve explanted livers. Normothermic machine perfusion (NMP) mimics the physiological state, and is conducted at 37 C. The liver is metabolically active, allowing for ex-situ real-time assessment of viability. Hypothermic oxygenated machine perfusion (DHOPE), conducted at 4 - 14C, has been demonstrated to improve the quality of ECD livers. This protocol is designed to assess viability of high risk donor livers using NMP, prior to transplantation. DHOPE, being superior in optimizing the quality of ECD livers will be conducted before gradually rewarming the donor liver to a normothermic temperature. During NMP a viability assessment will be carried out. Thus, high risk donor livers that would previously not have been accepted for transplantation, will be transplanted when meeting the viability criteria. Therefore, the donor pool might be expanded.
- Main changes (audit trail)
- RECORD19-jul-2016 - 7-feb-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl