NCT04070612

National Prospective Cohort for Monitoring Children With Severe Autoimmune Cytopenia.

National Prospective Cohort for Monitoring Children With Severe Autoimmune Cytopenia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 122 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cytopenia
• Autoimmune Haemolytic Anaemia
• Thrombocytopenic Purpura, Immune

Interventions

Type	Name	Description
OTHER	Blood sample	A blood sample of 2 times 2 to 5 ml additional maximum

Timeline

• Start date: 2007-04-04
• Primary completion: 2012-06-08
• Completion: 2012-06-08
• First posted: 2019-08-28
• Last updated: 2019-08-28