An observational study in Cytopenia, Autoimmune Haemolytic Anaemia and Thrombocytopenic Purpura, Immune, sponsored by University Hospital, Bordeaux. Completed. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by University Hospital, Bordeaux · Observational
This study aims to study prospectively the clinical and paraclinical evolution and prognostic factors of autoimmune haemolytic anemias, Evans syndromes and chronic immunological thrombocytopenic purpura of children in France.
These autoimmune haematological diseases are rare diseases affecting the child, often very young, and serious and potentially life-threatening. International literature data are scarce, and include individual cases or small series.
They do not allow to determine an optimal therapeutic strategy in case of escape from the first-line treatments. Existing treatments (long-term corticosteroid therapy, immunoglobulins, splenectomy, immunosuppressants, chemotherapies, and more recently anti-CD20 antibodies) are inconsistently effective, and often associated with serious side effects.
The seriousness of these diseases, the therapeutic difficulties, and the absence of a targeted research project in France, led to the implementation of this study.
This study aims to study prospectively the clinical and paraclinical evolution and prognostic factors of autoimmune haemolytic anemias, Evans syndromes and chronic immunological thrombocytopenic purpura of children in France.
85 studies on the registry are indexed under Cytopenia; 23 are open to participants now.
This study's enrollment of 122 is below the median of 200 across 19 observational studies indexed under Cytopenia.
Browse Cytopenia studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A blood sample of 2 times 2 to 5 ml additional maximum
Other: Blood sample
A blood sample of 2 times 2 to 5 ml additional maximum
Other: Blood sample
A blood sample of 2 times 2 to 5 ml additional maximum
Other: Blood sample
A blood sample of 2 times 2 to 5 ml additional maximum
Complete sustainable remission (yes/no) for children with autoimmune haemolytic anemias
Absence of clinical signs of anemia (grade 0) And Hemoglobin \> 11 g / dl And reticulocytes \<120,000 / mm3 And haptoglobin\> 10 mg / dl And bilirubin \<10 mg / l or 17 μmol / l And no specific treatment for at least 12 months
Time frame: At the screening
complete remission (yes/no) for children with autoimmune haemolytic anemias
Absence of clinical signs of anemia (grade 0) And Hemoglobin\> 11 g / dl And reticulocytes \<120,000 / mm3 Regardless of the level of haptoglobin or bilirubin And specific treatment in progress or interrupted for less than 12 months
Time frame: At the screening
partial remission (yes/no) for children with autoimmune haemolytic anemias
Clinical Signs of Anemia (Grade 1 or 2) Or Hemoglobin from 7 to 11 g / dl Or reticulocytes\> 120,000 / mm3 Regardless of the level of haptoglobin or bilirubin
Time frame: At the screening
no response (yes/no) for children with autoimmune haemolytic anemias
Clinical Signs of Severe Anemia (Grade 3 or More) Or Hemoglobin \<7 g / dl
Time frame: At the screening
deceased patient (yes/no) for children with autoimmune haemolytic anemias
Death yes/no
Time frame: At the screening
Complete sustainable remission (yes/no) for children with chronic immunologic thrombocytopenic purpura
Absence of clinical signs of haemorrhage (grade 0) And platelets\> 100,000 / mm3 And no specific treatment for at least 12 months
Time frame: At the screening
complete remission (yes/no) for children with chronic immunologic thrombocytopenic purpura
Absence of clinical signs of haemorrhage (grade 0) And platelets\> 100,000 / mm3 And specific treatment in progress or interrupted for less than 12 months
Time frame: At the screening
partial remission (yes/no) for children with chronic immunologic thrombocytopenic purpura
Clinical Signs of Hemorrhage (Grade 1 or 2) Or platelets between 30,000 and 100,000 / mm3
Time frame: At the screening
no response (yes/no) for children with chronic immunologic thrombocytopenic purpura
Clinical Signs of Severe Hemorrhage (Grade 3 or Greater) Or Platelets \<30,000 / mm3
Time frame: At the screening
deceased patient (yes/no) for children with chronic immunologic thrombocytopenic purpura
Death yes/no
Time frame: At the screening
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux