Romiplostim in pediatric patients post hematopoietic stem cell transplantation for early platelet engraftment: An open label randomised controlled trial

•        After applying the eligibility criteria, written informed consent shall be taken from the parent/ legally appointed representative and assent shall be taken from the child. The eligible subjects then shall undergo randomization as described before.

 Intervention: Those assigned to the intervention arm shall receive romiplostim at a dose of 5 μg/kg subcutaneously (at a 45o angle) at the outer lateral aspect of the deltoid region of the right arm, keeping full aseptic precautions by the principal investigator. This injection shall be administered on day +1 of transplant , and shall be repeated on day+8. For haploidentical HSCT , the first dose will be administered on day +5 and the second dose on +12.The drug shall be supplied by the manufacturing company, Zydus Lifesciences Ltd. and it shall be reconstituted and stored as per the manufacturer’s instructions. The manufacturing company will not play any part in the study design, data collection or data analysis. Along with the intervention drug, standard of care shall continue as per the unit protocol. This shall also include filgrastim injection, according to the unit protocol.

Control: Those assigned control arm shall receive the standard of care as per the unit protocol, including filgrastim as applicable. No placebo shall be administered.

 Monitoring: Serial complete blood counts (CBC) shall be performed in both the groups daily till attainment of the primary endpoint of the study- a platelet count of 20,000/mm3 or above for three consecutive days, with no transfusion requirements in the last three days, followed by every alternate day, till day +28. CBC measurement shall be performed by automated blood cell counter machine under the SMART Laboratory, AIIMS.