se of platelet-improving medicine Romiplostim in Liver Transplant Patient
Phase 4
- Conditions
- Health Condition 1: K740- Hepatic fibrosis
- Registration Number
- CTRI/2024/04/066269
- Lead Sponsor
- Amrita School of Pharmacy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br> <br/ ><br>Timepoint: Baseline line(before drug administration) <br/ ><br>Post drug administration day 1 to day 14 <br/ ><br>
- Secondary Outcome Measures
Name Time Method To compare the incidence of thrombosis in the portal vein, hepatic vein & and hepatic artery in both groups. <br/ ><br>To quantify and analyse the platelet-derived growth factor, hepatocyte growth factor and vascular endothelial growth factor in romiplostim and control group. <br/ ><br>The necessity to temporarily suspend the use of antimetabolite drugs such as mycophenolate mofetil or azathioprine following transplantation in both groups. <br/ ><br>Comparison of the number of platelet transfusions required in romiplostim & and control group <br/ ><br>To compare the occurrence of early allograft dysfunction. <br/ ><br>To compare the cost-effectiveness between both groups <br/ ><br>Timepoint: within 2 weeks