Reduction of Adverse Events and Re-Presentation to Medical Care After Intravenous Immunoglobulin Treatment in Children With Immune Thrombocytopenia With a Scheduled Post-Infusion Medication Strategy

Who is this study for? Children with immune thrombocytopenia
What treatments are being studied? Acetaminophen+Diphenhydramine
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of ITP confirmed by hematology team.

• Patient receiving IVIG for a clinical indication as determined by primary hematologist. IVIG can be administered in the inpatient, outpatient, and emergency room settings.

• Age 0 to 18 years

Locations
United States
Texas
Texas Children's Hospital
Houston
Time Frame
Start Date: 2021-09-02
Completion Date: 2023-10
Participants
Target number of participants: 20
Treatments
Experimental: Scheduled post-IVIG medication
Utilization of post-IVIG medication with acetaminophen and diphenhydramine on a scheduled basis of 72 hours post-infusion.
Sponsors
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov

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