Trial · NCT04741139
Post IVIG Medication in Children With Immune Thrombocytopenia
NCT04741139, Phase 1, Unknown, Baylor College of Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Post IVIG Medication in Children With Immune Thrombocytopenia. Trials, record NCT04741139. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04741139
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post IVIG Medication in Children With Immune Thrombocytopenia
- NCT number
- NCT04741139
- Status
- Unknown
- Phases
- Phase 1
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Immune Thrombocytopenia
- Interventions
- Acetaminophen and Diphenhydramine Only Product
- First posted
- 2021-02-05
- Last updated
- 2022-12-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Eligible Patients Agreeing to Enrollment | 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 | Percentage of Enrolled Patients who Achieve Medication Adherence | 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 |
| Secondary | Rate of Return to Medical Care for Emergent Evaluation | 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. |
| Secondary | Rates of IVIG-Associated Adverse Drug Events | 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. |
| Secondary | Rate of Laboratory Evaluation with Platelet Count During Emergent Medical Evaluation | 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. |
| Secondary | Rate of Patients Requiring Head CT During Emergent Medical Evaluation | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04741139
GET https://conductscience.org/api/trials/v1/NCT04741139/registered