A study on the pre-emptive use of Romiplostim to help platelets recover faster after blood and marrow transplant

INTERVENTION: Intervention1: Romiplostim: Prophylactic administration of Romiplostim from Day +1 of transplant, dose 5‐10 ug/kg with monitoring of platelet count and appropriate platelet transfusion till platelet engraftment Control Intervention1: Standard of care: Monitoring of platelet count and appropriate platelet transfusion till platelet engraftment CONDITION: Health Condition 1: T860‐ Complications of bone marrow transplant PRIMARY OUTCOME: 1. To evaluate time taken to reach a platelet count of 50,000 per microlitre or above, maintained for 3 consecutive days without transfusion support, in each of the two study arms. ; 2. To compare time taken to achieve platelet engraftment in both the study arms, defined as a platelet count of 20,000 per microlitre or more sustained for 7 consecutive days without transfusion support. ; 3. To quantify platelet transfusion requirement in the two randomized dose armsTimepoint: Platelet counts and transfusion requirement will be checked WEEKLY. SECONDARY OUTCOME: To assess incidence of primary failure of platelet engraftment, secondary failure of ; platelet recovery, graft failure in hematopoietic stem cell transplant recipientsTimepoint: Day 100 post‐ transplant To assess incidence of thrombotic events, bleeding manifestations secondary to ; thrombocytopenia, platelet overshoots, defined as platelet counts of more than 3,50,000 per microlitre, and other adverse events in both the arms.Timepoint: Day 100 post‐ transplant To compare the number of days of platelet transfusion requirement or grade 4 ; thrombocytopenia in both the study arms, after HSCT.Timepoint: Day 100 post‐ transplant To compare the number of doses of romiplostim required to achieve platelet counts of ; 50,000 per microlitreTimepoint: Weekly To evaluate durability of response in platelet counts in the two study arms by ; measuring platelet counts at day 100 post‐ transplant.Timepoint: Day 100 post‐ transplant INCLUSION CRITERIA: 1. Adults and children greater than or equal to 2 years of age, of all sex. 2. Undergoing HSCT irrespective of underlying disorder, where HSCT is indicated. 3. Receiving peripheral blood stem cell transplant, bone marrow graft, umbilical cord stem cell transplant 4. ECOG performance status less than or equal to 2 5. Normal liver and kidney function tests 6. Participant and or Participants legally acceptable representative is ready to give written informed consent and assent as applicable