Assessment of Safety and Efficacy of Romiplostim in Live Donor Liver Transplant Recipients- A Prospective Randomized Open Label Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief Summary
Following liver transplantation, thrombocytopenia is the common accompaniment within 0-5 days. Recovery to normalcy may take over 2-3 weeks in 60% of patients. Thrombocytopenia during this period may lead to bleeding from the operated or remote sites such as the brain. • Additionally, it is thought that thrombocytopenia has a propensity to exaggerate infection leading to graft failure, even to mortality. This is because platelets contain several growth factors, platelet-derived growth factors, insulin-like growth factors, hepatocyte growth factors, vascular endothelial growth factors as well as numerous cytokines. Romiplostim is more or less proven in thrombocytopenia following stem cell transplantation However it’s role in liver transplantation is not known . Our study aims to assess the efficacy and safety of romiplostim in live donor liver transplantation
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
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
- •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.
Outcomes
Primary Outcomes
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
Time Frame: Baseline line(before drug administration) | Post drug administration day 1 to day 14
Secondary Outcomes
- 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.)
Investigators
Dr S Sudhindran
Amrita institute of Medical Sciences Kochi