Development of chronic disease in newly diagnosed Idiopathic Thrombocytopenic Purpura of Childhood. A randomized controlled study on the influence of treatment with intravenous gammaglobulin on the course of the disease. - The TIKI study : Treatment with or without IVIG in Kids with acute ITP

niversitair Medisch Centrum Utrecht0 个研究点目标入组 200 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•General inclusion criteria
•- Children aged 3 months -16 years, presenting to a pediatrician with newly diagnosed acute ITP and
•- Platelet count < 20 x 10 9 /L and
•- Bleeding tendency < grade 4 (Buchanan) and
•- no prior immunomodulating treatment within 4 weeks before diagnosis and
•- signed informed consent by parents and/ or patients

•A patient presenting with any of the following criteria will not be included in the study:;General exclusion criteria
•- clinical features that are not compatible with the diagnosis of acute ITP, for example: presence of other auto-immune phenomena, organomegaly, other cytopenias besides thrombocytopenia or features susceptible for infectious disease like hepatitis, Epstein-Barr virus or HIV
•- immunomodulating treatment (IVIG, corticosteroids) within 4 weeks before diagnosis
•- history of allergic reactions against human plasma, plasma products or intravenous immunoglobulin
•- Severe or life threatening bleeding at presentation: grade 4 or 5 (Buchanan)
•- No informed consent

发起方

niversitair Medisch Centrum Utrecht