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NCT03098043
Post-Static Cold Storage Hypothermic Oxygenated Perfusion in Bergamo Liver Transplant Program
trial in Liver Transplantation in 20 participants. Status unknown.
3 December 2021
Quick facts
| Lead sponsor | Papa Giovanni XXIII Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 5 November 2017 |
| Primary completion | 3 December 2021 |
| Estimated completion | 3 December 2021 |
| Sites | 1 location across Italy |
Conditions studied
- Liver Transplantation — all drugs for Liver Transplantation →
Sponsor
Papa Giovanni XXIII Hospital
Who can join
Adults 30 Days to 70, any sex, with Liver Transplantation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Hypothermic oxygenated machine perfusion (HOPE) for orthotopic liver transplantation of human liver allografts from extended criteria donors (ECD) in donation after brain death (DBD): a prospective multicentre randomised controlled trial (HOPE ECD-DBD).
Czigany Z, Schöning W, Ulmer TF, Bednarsch J, et al · · 2017 · cited 56× · PMID 29018070 · DOI 10.1136/bmjopen-2017-017558
Verify or expand the search:
- PubMed search for NCT03098043
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Liver Transplantation
Currently open trials in the same condition.
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- NCT06717919 — HOPE Against Cancer Recurrence in HCC · Phase 4 · recruiting
- NCT06868589 — Reducing Pain With Methadone and Ketamine in Liver Transplant · Phase 4 · active not recruiting
- NCT06874296 — Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time · NA · recruiting
Other Papa Giovanni XXIII Hospital trials
Trials by the same sponsor.
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- NCT06480253 — Cerebral Blood Flow: Helmet vs Oronasal Mask During Continuous Positive Airway Pressure Ventilation · NA · not yet recruiting
- NCT07290582 — Phrenic Infiltration as Cryoanalgesia Adjuvant for Early Postoperative Pain Following the Nuss Procedure · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03098043 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Papa Giovanni XXIII Hospital
- Last refreshed: 26 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03098043.
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