Immune Thrombocytopenia Clinical Trial
Official title:
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
Verified date | December 2022 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | October 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Eligible Patients Agreeing to Enrollment | Patients who are considered eligible for study participation and are approached by the research team to participate will be included in the determination of enrollment feasibility. | 12 months | |
Secondary | Percentage of Enrolled Patients who Achieve Medication Adherence | Patients and families will be considered adherent to the medication regimen if >75% of the scheduled doses are administered (average of 3 of 4 daily doses given). A patient must meet the following two criteria to be considered adherent:
The patient received on average at least 75% of the scheduled doses across the 72 hours study period The patient received at least 75% of the doses scheduled to be given within the first 24 hours of the study period |
12 months | |
Secondary | Rate of Return to Medical Care for Emergent Evaluation | The rate of return to medical care for emergent evaluation, along with additional clinical outcomes as detailed in outcomes 4-6, will be collected. This rate 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. This data will provide important preliminary clinical data regarding rates of return to medical care and additional medical interventions. | 72 hours following IVIG for each patient | |
Secondary | Rates of IVIG-Associated Adverse Drug Events | The rates of headache, nausea/vomiting, and other patient reported adverse event following IVIG 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. This data will provide important preliminary clinical data regarding rates of return to medical care and additional medical interventions. | 72 hours following IVIG for each patient | |
Secondary | Rate of Laboratory Evaluation with Platelet Count During Emergent Medical Evaluation | In addition to the rate at which patients return to medical care for emergent evaluation after IVIG, the rate of subsequent laboratory evaluation, specifically platelet count, will be collected. This rate 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. This data will provide important preliminary clinical data regarding rates of return to medical care and additional medical interventions. | 72 hours following IVIG for each patient | |
Secondary | Rate of Patients Requiring Head CT During Emergent Medical Evaluation | The rate of patients who require CT of the head during return to medical care for emergent evaluation will be collected. This rate 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. This data will provide important preliminary clinical data regarding rates of return to medical care and additional medical interventions. | 72 hours following IVIG for each patient |
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