An interventional study of Hypothermic Machine Perfusion and Normothermic Machine Perfusion in End Stage Liver DIsease, sponsored by Azienda Ospedaliero, Universitaria Pisana. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-26.
Sponsored by Azienda Ospedaliero, Universitaria Pisana · Not applicable, Interventional, and Treatment
Study groups:
The study is a multicenter (Pisa and Milan), prospective, randomized study comparing D-HOPE (HMP) vs NMP in DCD and ECD-DBD (extended criteria brain-dead donors). Once a DCD or a DBD with extended criteria (ECD-DBD) meets the inclusion criteria, they are randomized as follow:
The persistent mismatch between patients waiting for a liver transplant (LT) and grafts availability promoted the use of donation after circulatory death (DCD). Italian law requires 20 minutes of continous flatline electrocardiogram to declared individual's circulatory death and such a long period of warm ischemia time forced the development of protocols using abdominal normothermic regional perfusion (NRP) followed by ex-vivo graft reperfusion by means of machine perfusion technology (MP) for its potential to minimize ischemia/reperfusion damage and promote organ repair and reconditioning prior to transplantation. An extensive evaluation of all DCD donors might increase donation rate by 30%, but, while kidney transplant from DCD donors is well implemented, no definitive data exist on the optimal use of NRP and MP in liver and pancreas transplantation and an organizational model is far to be implemented. Moreover, a randomized trial comparing hypothermic vs normothermic ex-vivo perfusion has never been performed. The proposed project will perform a pilot, open, randomized, prospective trials to evaluate the sequential use of NRP followed by ex-vivo MP (hypothermic (HMP) vs normothermic (NMP)) by measuring several indicators of organ damage and recovery with the target to set up the optimal organizational model for DCD donation:
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Azienda Ospedaliero, Universitaria Pisana is the lead sponsor of 56 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
GRAFT:
Inclusion criteria:
DCD:
DBD:
Exclusion criteria:
DCD:
DBD:
RECIPIENTS
Inclusion criteria:
Exclusion criteria:
uDCD and cDCD after Normothermic Regional Perfusion matching the inclusion criteria, ECD matching the inclusion criteria, uDCD and cDCD exceeding the inclusion criteria.
Device: Hypothermic Machine Perfusion
uDCD and cDCD after Normothermic Regional Perfusion matching the inclusion criteria, ECD matching the inclusion criteria, uDCD and cDCD exceeding the inclusion criteria.
Device: Normothermic Machine Perfusion
The perfusion system was primed with 4 L of Belzer machine perfusion solution University of Wisconsin Machine Perfusion Solution (Bridge for Life, Ltd., Columbia, SC). The arterial and portal pressures were set at 25 mm Hg with a flow and at 3-4 mm Hg with a continuous flow, respectively. The oxygen flow was set at 0.25 L/minute. The target liver temperature was between 4°C and 10°C.
Also known as: Hypothermic machine perfusion (HMP)
Grafts were perfused at 37°C in an OR next to the transplant OR and under medical supervision using a blood-based perfusate. Initial perfusate temperature was set at 20°C and raised by 1°C every 2 minutes. Oxygenation was provided by an anesthesia ventilator initially set at 4 L/minute with 30% fraction of inspired oxygen, and later adjusted based on perfusate pH, partial pressure of oxygen, and partial pressure of carbon dioxide. Blood gas analyses were drawn every 20 minutes during the first hour and every 30 minutes thereafter with the aim to maintain a physiological pH and ionogram result, and a partial pressure of oxygen between 200 and 250 mm Hg. Perfusate glucose, transaminases, and lactate were measured during NMP as were bile production and quality (pH, sodium, glycemia, lactate, and HCO3)
Also known as: Normothermic machine perfusion (NMP)
Rate of graft loss
Death of patient, relisting or Retransplantation. Composite Outcome
Time frame: at 6 months postoperatively
Rate of Ischemic Type Biliary Lesions (ITBL)
ITBL as assessed by MRI / MRCP. Composite Outcome
Time frame: at 6 months postoperatively
1-year graft survival
Time frame: 1-year postoperatively
1-year patients survival
Time frame: 1-year postoperatively
level of BCL-2/BAX at the liver histology
BCL-2/BAX is members of the Bcl-2 family of regulator proteins that regulate cell death and correlates with graft loss
Time frame: after 2 hours of perfusion
level of Soluble Keratin 18 in the perfusate
Soluble Keratin 18 is a marker of necrosis and apoptosis and correlates with graft loss
Time frame: after 2 hours of perfusion
level of HMGB1in the perfusate
HMGB1 Acts as danger associated molecular pattern (DAMP) molecule that amplifies immune responses during tissue injury and correlates with graft loss
Time frame: after 2 hours of perfusion
Plan to share: No
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Azienda Ospedaliero, Universitaria Pisana