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

niversity Medical Center Utrecht0 个研究点目标入组 300 人开始时间: 2008年5月29日最近更新: 2018年9月3日

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
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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

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