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ENROLLING BY INVITATION
NCT07003256

Observational Study: Romiplostim for Platelet Recovery in Haploidentical HSCT

Sponsor: Haikou Affiliated Hospital of Central South University Xiangya School of Medicine

View on ClinicalTrials.gov

Summary

The objective of this observational study is to explore the long-term effects of roprastine given to promote platelet implantation in hematopoietic stem cell hemicongruent transplantation in children with thalassemia. The main questions it aimed to answer is: Is roprastine safe and effective for platelet implantation in children with thalassemia hemicongruent transplantation? Participants who have already received roprastine as part of routine medical care for hematopoietic stem cell hemicongruent transplantation in children with thalassemia will answer online survey questions about the effects of their platelet implantation within 8 weeks.

Official title: An Observational Study on the Promotion of Platelet Recovery by Romiplostim During Haploidentical Hematopoietic Stem Cell Transplantation

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2024-09-01

Completion Date

2026-04-30

Last Updated

2025-06-06

Healthy Volunteers

No

Interventions

DRUG

Romiplostim

After transplantation + 6 days, the subcutaneous injection of roprastine 3ug/kg was started, and the number of platelets in the machine-taken platelet suspension was increased by 2 µg/kg per week, and the maximum dose was 10 μg/kg. Discontinued until platelets rose to 100 × 109/L. If platelets ≤ 20 X 109/L were used for + 20 days, roprastine combined with atropopa 25mg was given orally once a day. Patients were given 1 therapeutic dose of fresh machine-taken platelet suspension when platelets were ≤ 20 X 109/L, or when there was active bleeding at 21\~ 50 × 109/L. The number of platelets in the machine-taken platelet suspension per therapeutic dose was \> 2.5 × 1011. If not implanted at + 28 days after transplantation, re-transplantation is required, and roprastine is considered ineffective.

Locations (1)

Haikou Affiliated Hospital of Central South University Xiangya School of Medicine

Haikou, Hainan, China