An observational study in Immune Thrombocytopenia, Autoimmune Hemolytic Anemia and Evans Syndrome, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 6 Months to 25 Years. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Medical University of Graz · Observational
Prospective registry study for children and young adults with severe immune cytopenias (persisting/chronic immune thrombocytopenia, autoimmune hemolytic anemia, and Evans syndrome) to improve the management, facilitate the differential diagnostic work-up, and document the clinical course under various treatments.
Time points: at inclusion, after 6 months, after 12 months, then yearly up to 4 years after inclusion.
No intervention, mere observation and documentation. Guided pre-inclusion (differential) diagnostic work-up.
The study aims to improve the management and care of patients with severe immune cytopenias, to identify underlying causes of severe immune cytopenias and to develop a strategy for early treatment stratification based on a standardized diagnostic algorithm, potentially supported by biomarker analyses and (off study) genetic analyses, where clinically indicated.
Primary Goal:
Rapid detection of underlying causes of severe immune cytopenias with the aid of a structured diagnostic approach and access to a clinical care network of the participating centers, allowing early treatment stratification
Secondary Goals:
There will be no additional venous punctures or investigational time points. At clinical visits around planned study time points, additional blood parameters and stool specimen will be obtained. The current clinical management follows international guidelines, which are summarized in the study documents but do not represent part of the study (no diagnostic or therapeutic investigational arm).
503 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 158 are open to participants now.
This study's enrollment of 80 is below the median of 122 across 99 observational studies indexed under Purpura, Thrombocytopenic, Idiopathic.
Browse Purpura, Thrombocytopenic, Idiopathic studies →Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
consecutive registration of pediatric, adolescent, and young adult patients with severe immune cytopenia who consent
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
all who fulfil inclusion criteria and consent to participation; potential biomarkers will be documented
Diagnostic Test: potential biomarkers
facs analysis, microbiome analysis
underlying disease that causes or is associated with severe immune cytopenia
identify the underlying condition or other disease, e.g., primary immunodeficiency or bone marrow failure syndrome by diagnostic procedures according to a standardized algorithm
Time frame: 0-4 years
Clinical course
Documentation of physician-reported clinical symptoms including outcome measures/performance scores
Time frame: 0-4 years
Biomarkers - Blood
Identification of novel biomarkers by flow cytometry of leukocytes
Time frame: 0-4 years
Biomarkers - Stool
Identification of potential modifiers of immune tolerance by studying the intestinal microbiome
Time frame: 0-4 years
Routine laboratory parameters
documentation of laboratory parameters that are routinely assessed for immune cytopenia
Time frame: 0-4 years
Number of participants with the diagnosis of severe immune cytopenia per participating centre and per year
epidemiological data acquisition, participants included according to the inclusion criteria
Time frame: 0-4 years
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Dec 2023, 69 months.
Of 31 observational studies under Purpura, Thrombocytopenic, Idiopathic, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 35. This study's 69 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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