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Post IVIG Medication in Children With Immune Thrombocytopenia

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ClinicalTrials.gov Identifier: NCT04741139
Recruitment Status : Recruiting
First Posted : February 5, 2021
Last Update Posted : April 12, 2022
Sponsor:
Information provided by (Responsible Party):
Jenny Despotovic, Baylor College of Medicine

Brief 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.


Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Acetaminophen and Diphenhydramine Only Product Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 20, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023


Arm Intervention/treatment
Experimental: Scheduled post-IVIG medication
Utilization of post-IVIG medication with acetaminophen and diphenhydramine on a scheduled basis of 72 hours post-infusion.
Drug: Acetaminophen and Diphenhydramine Only Product
Using a scheduled medication regimen of diphenhydramine and acetaminophen following IVIG medication to evaluate feasibility of enrollment, medication adherence, side effects related to study medication and IVIG.




Primary Outcome Measures :
  1. Percentage of Eligible Patients Agreeing to Enrollment [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Percentage of Enrolled Patients who Achieve Medication Adherence [ Time Frame: 12 months ]

    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:

    1. The patient received on average at least 75% of the scheduled doses across the 72 hours study period
    2. The patient received at least 75% of the doses scheduled to be given within the first 24 hours of the study period

  2. Rate of Return to Medical Care for Emergent Evaluation [ Time Frame: 72 hours following IVIG for each patient ]
    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.

  3. Rates of IVIG-Associated Adverse Drug Events [ Time Frame: 72 hours following IVIG for each patient ]
    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.

  4. Rate of Laboratory Evaluation with Platelet Count During Emergent Medical Evaluation [ Time Frame: 72 hours following IVIG for each patient ]
    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.

  5. Rate of Patients Requiring Head CT During Emergent Medical Evaluation [ Time Frame: 72 hours following IVIG for each patient ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04741139


Contacts
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Contact: Jenny Despotovic, MD 832-822-4242 jmdespot@texaschildrens.org

Locations
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United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Jenny Despotovic, MD    832-822-4242    jmdespot@texaschildrens.org   
Sponsors and Collaborators
Baylor College of Medicine
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Responsible Party: Jenny Despotovic, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04741139    
Other Study ID Numbers: H-47160
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Thrombocytopenia
Immune System Diseases
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Acetaminophen
Diphenhydramine
Promethazine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Local
Anesthetics
Antiemetics
Autonomic Agents