International Second Immunoglobulin Dose in Guillain-Barre Syndrome patients with poor prognosis. - I-SID GBS study

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Patients are diagnosed with GBS according to NINDS diagnostic criteria.(3)
•Indication to start IVIg treatment:
•1. Patient is unable to walk unaided for >10 meter (grade 3, 4 or 5 of the GBS disability scale)
•2. There is otherwise an indication to start IVIg treatment according to the treating neurologist
•Onset of weakness due to GBS is less than 2 weeks ago.
•Signed informed consent.

•Age less than 6 years
•Patient known to have a severe allergic reaction to properly matched blood products or plasma products.
•Pregnancy or breastfeeding.
•Patient known to have a selective IgA deficiency.
•Patient shows clear clinical evidence of a polyneuropathy caused by e.g. diabetes mellitus (except mild sensory), alcoholism, severe vitamin deficiency, porphyria.
•Patient received immunosuppressive treatment (e.g. azathioprine, cyclosporine, mycofenolatemofetil, tacrolimus, sirolimus or > 20 mg prednisolon daily) during the last month.
•Patient known to have a severe concurrent disease, like malignancy, severe cardiovascular disease, AIDS, severe COPD.
•Inability to attend follow-up during 6 months.
•Relative contra-indications for second IVIg dose:
•Patients known to have severe kidney dysfunction (GFR below 40 ml/min).
•Pre-existing risk factors of thrombo-embolic complications or severe ischemic heart disease.

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