Overview

Post IVIG Medication in Children With Immune Thrombocytopenia

Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
This study is a single hospital system, single-arm year-long pilot to evaluate the feasibility of enrolling children with ITP who are receiving IVIG for treatment of disease to a scheduled post-infusion medication for 72 hours following IVIG infusion. This year-long feasibility pilot will test the (1) feasibility of enrollment and the willingness of families to participate in a scheduled medication regimen and (2) adherence of patients and families to the scheduled medication regimen. Clinical outcomes, as defined by rates of headache or nausea/vomiting or other adverse event following IVIG, return to medical care, and need for further laboratory or imaging studies, will be collected. These rates will be compared to retrospective, historical data from Texas Children's Hematology Center from 2010 to 2019. However, due to the rate at which these events occur following IVIG, this feasibility pilot is not fully powered to detect differences in clinical outcomes.
Phase:
Phase 1
Details
Lead Sponsor:
Baylor College of Medicine
Treatments:
Acetaminophen
Diphenhydramine
Promethazine