Clinical trial NCT03930459: Efficacy of Ex-situ Normothermic Perfusion Versus Cold Storage in the Transplant With Steatotic Liver Graft.
Official title: Clinical Trial to Compare the Efficacy of Ex-situ Normothermic Perfusion With Cold Storage in the Transplant With Steatotic Liver Graft.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Transplant
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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)

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

Primary outcomes:
measure: Peak of transaminases (AST and ALT)
timeFrame: Day 1 post-transplant.
measure: Peak of transaminases (AST and ALT)
timeFrame: Day 3 post-transplant.
measure: Peak of transaminases (AST and ALT)
timeFrame: Day 5 post-transplant.
measure: Peak of transaminases (AST and ALT) l
timeFrame: Day 7 post-transplant.
Secondary outcomes:
measure: Primary graft failure
timeFrame: Day 10 post-transplant.
measure: Graft survival
timeFrame: Day 30 post-transplant, month 6 post-transplant, month 12 post-transplant.
measure: Patient survival
timeFrame: Day 30 post-transplant, month 6 post-transplant, month 12 post-transplant.
measure: Post-reperfusion syndrome, measured by mean arterial pressure (MAP) levels
timeFrame: During the first 5 minutes after reperfusion
measure: Biochemical function of the liver measured by Bilirubin post-transplant levels
timeFrame: Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant
measure: Biochemical function of the liver measured by GGT post-transplant levels
timeFrame: Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant
measure: Biochemical function of the liver measured by AST post-transplant levels
timeFrame: Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant
measure: Biochemical function of the liver measured by ALT post-transplant levels
timeFrame: Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant
measure: Biochemical function of the liver measured by INR post-transplant levels
timeFrame: Day 1, day 3, day 5, day 7, day 30, month 6, month 12 post- transplant
measure: Early graft dysfunction
timeFrame: 7 days post-transplant
measure: Intensive care stay duration
timeFrame: Day 30
measure: Hospital stay duration
timeFrame: Day 30
measure: Renal replacement therapy need
timeFrame: Day 30, month 6, month 12 post- transplant
measure: Intraoperative thromboelastogram result
timeFrame: In transplant surgery
measure: Histological evidence of reperfusion injury
timeFrame: In transplant surgery
measure: Evidence of biliary stenosis in magnetic resonance cholangiography (MRS).
timeFrame: 6 months after transplantation.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
Study officials:
References:
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