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A randomized, single-blind, controlled clinical trial design to evaluate the effectiveness and safety of methylprednisolone in patients with early post-operative hyperbilirubinemia after liver transplantation from donation after citizen’s death

A randomized, single-blind, controlled clinical trial design to evaluate the effectiveness and safety of methylprednisolone in patients with early post-operative hyperbilirubinemia after liver transplantation from donation after citizen’s death

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16009576
Enrollment
Unknown
Registered
2016-10-24
Start date
2016-07-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Early post-operative hyperbilirubinemia after liver transplantation

Interventions

Trial group:Methylprednisolone 1mg/Kg iv qd + Ursodeoxycholic Acid 250mg po tid for 5 days
Control Group:Ursodeoxycholic Acid 250mg po tid for 5 days

Sponsors

Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients following OLT from donation after Chinese citizens death; 2. Donor's aged 14 years to 60 years, recipient's aged 14 years to 65 years; 3. TBIL >171µmol/L within 7-14 days after OLT, or TBIL 51µmol/L and is still rising for at least 3 days; 4. Patients and their families have signed informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria of patient: 1. Severe sepsis 2. Postoperative graft rejection 3. Postoperative biliary complications and vascular complications 4. Primary disease recurrence after OLT 5. Postoperative hemolytic icterus 6. TBIL >171µmol/L within 7-14 days after OLT but decreasing for at least 3 days 7. Blood group incompatibility between donor and recipient 8. Allergic to glucocorticoids 9. Has a history of severe diabetes or gastric ulcer 10. Has a history of pregnancy 11. Split liver transplant recipients 12. Families are reluctant to participate in the study or have not signed informed consent form. Exclusion criteria of donor: 1. Aged>60-year-old; 2. HBV or HCV infection; 3. Gilbert syndrome; 4. Weight of graft is less than 0.8% of recipient's weight; 5. Find parasites in graft.

Design outcomes

Primary

MeasureTime frame
Total bilirubin;

Countries

China

Contacts

Public ContactHe Xiaoshun

Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University

gdtrc@163.com+86 20 87306082

Outcome results

None listed

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