HOPE for Small grafts in Living Donor Liver Transplantatio
- Conditions
- Health Condition 1: - Health Condition 2: O- Medical and Surgical
- Registration Number
- CTRI/2023/06/053391
- Lead Sponsor
- Mohamed Rela
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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 <0.7 (study arm II: cold storage with 2hrs HOPE) and =0.7 (Study arm I: standard cold storage)
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoint: <br/ ><br>SFSS (Small for size Syndrome) , EAD (Early Allograft Dysfunction )Timepoint: 3 months
- Secondary Outcome Measures
Name Time Method 1.Need for intraoperative flow modulation (surgical: Splenic Artery Ligation, Splenic Embolisation, Porto caval-shunt, pharmacological…) or postop interventions <br/ ><br>2.Intraoperative RBC, FFP trasnfusions <br/ ><br>3.Lactate end of Orthotopic Liver Trasnplantation(OLT), pharmacological support end of OLT <br/ ><br>4.HOPE perfusate: FMN, NADH, oxygenation <br/ ><br>5.ICU, hospital stay <br/ ><br>6.Transaminases 1st week including peak <br/ ><br>7. INR 12 and 24hrs and day 7 after OLT <br/ ><br>8.Lactate 6, 12, 24hrs after OLT <br/ ><br>9.Bilirubin day 7 <br/ ><br>10.AKI rate, need for dialysis/CVVH and duration <br/ ><br>11.Pharmacological support <br/ ><br>12.Biliary, vascular com1plications <br/ ><br>13.Sepsis/infection <br/ ><br>14.Major complication & CCI(comprehensive Complication Index in hospital, 3m, 12m after OLT <br/ ><br>15. Graft/patient survival within 1y after OLT <br/ ><br>Timepoint: in hospital, 3, 6, 9, 12 months