Use of platelet-improving medicine Romiplostim in Liver Transplant Patient

Assessment of Safety and Efficacy of Romiplostim in Live Donor Liver Transplant Recipients- A Prospective Randomized Open Label Trial - not applicable

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066269

Enrollment

Registered

2024-04-24

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: K740- Hepatic fibrosis

Interventions

Intervention1: Romiplostim, 250mcg subcutameously. Romiplostim may be administered after every 3 days if the platelet count does not go above 40000 platelets per cubic millimeter.: Romiplostim is a th

Eligibility

Inclusion criteria

Inclusion criteria: Patient with the age group of 18-65years. Patients with a platelet count below 40000 Patient who signed the informed consent form

Exclusion criteria

Exclusion criteria: Pregnancy, age under 18 or over 65, ongoing multiple organ failure, antiplatelet therapy, suspected/ diagnosed heparin-induced thrombocytopenia or innate/acquired thrombophilia. Patients with myelodysplastic or myeloproliferative syndrome, hematological malignancy, and aplasia diagnosed on bone marrow. severe liver cirrhosis with a Child-Pugh score superior to 6, or a medical history of pulmonary embolism/stroke in the previous 6 months were also excluded.

Design outcomes

Primary

Measure	Time frame
To determine the number of days required for normalization of the platelet count in the romiplostim group compared to the control group following live donor liver transplantation Timepoint: Baseline line(before drug administration) Post drug administration day 1 to day 14	—

Secondary

Measure	Time frame
To compare the incidence of thrombosis in the portal vein, hepatic vein & and hepatic artery in both groups. To quantify and analyse the platelet-derived growth factor, hepatocyte growth factor and vascular endothelial growth factor in romiplostim and control group. The necessity to temporarily suspend the use of antimetabolite drugs such as mycophenolate mofetil or azathioprine following transplantation in both groups. Comparison of the number of platelet transfusions required in romiplostim & and control group To compare the occurrence of early allograft dysfunction. To compare the cost-effectiveness between both groups Timepoint: within 2 weeks	—

Measure

Time frame

To compare the incidence of thrombosis in the portal vein, hepatic vein & and hepatic artery in both groups. To quantify and analyse the platelet-derived growth factor, hepatocyte growth factor and vascular endothelial growth factor in romiplostim and control group. The necessity to temporarily suspend the use of antimetabolite drugs such as mycophenolate mofetil or azathioprine following transplantation in both groups. Comparison of the number of platelet transfusions required in romiplostim & and control group To compare the occurrence of early allograft dysfunction. To compare the cost-effectiveness between both groups Timepoint: within 2 weeks

—

Countries

India

Contacts

Public ContactDr S Sudhindran

Amrita institute of Medical Sciences Kochi

anjusnair546@gmail.com9207082076

Outcome results

None listed

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