Second IVIg Dose in GBS patients with poor prognosis (SID-GBS trial) - SID-GBS trial

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 339 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Patients are diagnosed with GBS.
•There is an indication to start IVIg therapy:
•1. Patient is unable to walk unaided for >10 meter (grade 3, 4 or 5 of the GBS disability scale) or 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 12 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, mycofenolaatmofetil, 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 CARA.
•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.
•Contra-indications for GPO:
•proven hypersensitivity to albumin products
•every situation in which hypervolaemia or haemodilution can form a special risk; examples of such conditions are: heart failure, severe hypertension, oesophageal varices, pulmonary oedema, haemorrhagic diathesis, severe anaemia, renal and postrenal anuria

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