A clinical trial to test the use of a drug called Romiplostim in children after stem cell transplantation for early platelet recovery
Phase 3
- Conditions
- Health Condition 1: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue
- Registration Number
- CTRI/2024/03/064716
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
undergoing allogenic or autologous hematopoietic stem cell transplantation
Exclusion Criteria
1. History of thrombotic events in the past
2. Received thrombopoietic agents in the past
3. non consenting guardian
4. Second transplant
5. Bone marrow not in remission at the transplant
6. Reduced-intensity conditioning transplant
7. Umbilical cord blood transplant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the number of days to platelet engraftment, in children aged between 1 and 18 years, post hematopoietic stem cell transplantation, between the control and intervention groups. <br/ ><br> <br/ ><br>Timepoint: Day of platelet engraftment <br/ ><br>(expected between 12-18 days as per retrospective cohort) <br/ ><br>
- Secondary Outcome Measures
Name Time Method To compare the following parameters between children aged 1 to 18 years requiring stem cell transplantation and controls- <br/ ><br> <br/ ><br>Need for platelet transfusions <br/ ><br>Platelet count at day +28 <br/ ><br>Depth of platelet nadir <br/ ><br>Number of significant bleeding episodes <br/ ><br>Rates of thrombotic eventsTimepoint: Need for platelet transfusions till engraftment <br/ ><br>thrombotic events clinical follow up till 3 months post last dose of drug <br/ ><br>