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Post-Static Cold Storage Hypothermic Oxygenated Perfusion in Bergamo Liver Transplant Program

NCT03098043 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2019-11-26

No results posted yet for this study

Summary

In light of the widespread organ shortage, dynamic preservation by means of Machine Perfusion (MP) has been proposed as a strategy to increase the pool of suitable grafts for liver transplantation. Reproducing more physiological conditions than traditional Static Cold Storage (SCS), MP may allow a better preservation and evaluation and perhaps even the resuscitation of high risk grafts. As a consequence, unnecessary discard of organs could be avoided and quality and safety of transplantation could be improved as well.

Hypothermic MP (HMP) seems to reduce ischemia-reperfusion injury. In fact, hypothermia slows down the metabolic rate and the oxygenation of the perfusate leads to re-synthesis of Adenosine TriPhosphate (ATP), which results in the restoration of cellular energy.

Four series about the use of HMP in the clinical setting has been published so far. They all report acceptable outcomes after transplantation of human liver grafts from extended criteria Brain Dead Donors (BDD) and from Donation after Circulatory Death (DCD) donors preserved by HMP, thus proving its feasibility and safety. The efficacy of HMP, instead, is still under investigation in a phase II randomized trial.

This is an observational, prospective, monocentric study aiming at verifying the feasibility and safety of post-SCS Hypothermic Oxygenated PErfusion (HOPE) in the setting of our liver transplant program. Extended criteria grafts from BDD and grafts from DCD donors will be preserved by post-SCS HOPE prior to transplantation. The recipients of these grafts will be followed-up for at least 1 year.

Conditions

  • Liver Transplantation

Sponsors & Collaborators

  • Papa Giovanni XXIII Hospital

    lead OTHER

Principal Investigators

  • Stefania Camagni, MD · Papa Giovanni XXIII Hospital

  • Michele Colledan, MD · Papa Giovanni XXIII Hospital

Eligibility

Min Age
30 Days
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-05
Primary Completion
2021-12-03
Completion
2021-12-03

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03098043 on ClinicalTrials.gov