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HOPE for Small grafts in Living Donor Liver Transplantation

Hypothermic Oxygenated Perfusion (HOPE) for transplantation of Living Donor Liver grafts prone to small for size syndrome - HOPEL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053391
Enrollment
50
Registered
2023-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Hypothermic oxygenated machine perfusion after static cold preservation: The Vivosmart platform was used for ex situ machine perfusion of the liver. The device enables pressure-control

Sponsors

Mohamed Rela
Lead Sponsor
Mauricio Carvalho
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Donor criteria: 1.Any living liver donor used for transplantation at Dr. Rela institute within the study period 2.Any type of donation surgery (open, robotic,..) 3.Any liver lobe (right, left) 4.GRWR Recipient Criteria: 1.Adult recipient (=18years of age) of living related liver transplantation at Dr. Rela Institute 2.Primary liver transplantation 3.Donor-recipient ABO compatible or incompatible 4.Lab MELD of =25points 5.Recipient with any chronic liver disease with or without cirrhosis with or without liver tumour (HCC, or other) 6.Consented recipient

Exclusion criteria

Exclusion criteria: 1.Recipient listed due to acute or subacute liver failure 2.Recipient listed for retransplantation 3.Recipients with known grade III or IV portal vein thrombosis 4.Recipients with combined transplantation (e.g., liver + kidney, liver + any other organ) Recipients with lab MELD >25points 5.Recipients with sepsis (ICU requirement) at the time of transplantation 6.Recipients with ventilation at time of transplantation

Design outcomes

Primary

MeasureTime frame
Primary Endpoint: SFSS (Small for size Syndrome) , EAD (Early Allograft Dysfunction )Timepoint: 3 months

Secondary

MeasureTime frame
1.Need for intraoperative flow modulation (surgical: Splenic Artery Ligation, Splenic Embolisation, Porto caval-shunt, pharmacological…) or postop interventions 2.Intraoperative RBC, FFP trasnfusions 3.Lactate end of Orthotopic Liver Trasnplantation(OLT), pharmacological support end of OLT 4.HOPE perfusate: FMN, NADH, oxygenation 5.ICU, hospital stay 6.Transaminases 1st week including peak 7. INR 12 and 24hrs and day 7 after OLT 8.Lactate 6, 12, 24hrs after OLT 9.Bilirubin day 7 10.AKI rate, need for dialysis/CVVH and duration 11.Pharmacological support 12.Biliary, vascular com1plications 13.Sepsis/infection 14.Major complication & CCI(comprehensive Complication Index in hospital, 3m, 12m after OLT 15. Graft/patient survival within 1y after OLT Timepoint: in hospital, 3, 6, 9, 12 months

Countries

India

Contacts

Public ContactSandeep Jasper Rajasekhar

Dr Rela Institute and Medical Centre

drsand2ep@yahoo.com9789410872

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026