Post IVIG Medication in Children With Immune Thrombocytopenia (NCT04741139) | Clinical Trial Compass
UnknownPhase 1
Post IVIG Medication in Children With Immune Thrombocytopenia
United States20 participantsStarted 2021-09-02
Plain-language 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.
Who can participate
Age range
1 Month – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Patients with a history of anaphylaxis to IVIG infusion.
* Patients receiving IVIG for indications other than ITP.
* Patients who have previously received IVIG or who receive multiple IVIG infusions within the study period.
* Patients who require additional platelet direct therapies including corticosteroids, anti-D immunoglobulin, rituximab, or thrombopoietin receptor agonists.
* Other cause of thrombocytopenia (congenital thrombocytopenias, drug induced thrombocytopenia, bone marrow failure, liver disease, etc.) apparent by history and physical examination, and/or laboratory tests.
* Inability to tolerate oral medications
* Other medical or social factors at discretion of treating physician such as ability to follow-up, etc.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Eligible Patients Agreeing to Enrollment