International Second Immunoglobulin Dose in Guillain-Barre Syndrome patients with poor prognosis.
- Conditions
- acute inflammatory demyelinating polyneuropathy (AIDP)Guillain-Barre syndrome1000381610034606
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
• 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)
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 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study endpoint<br /><br>GBS disability score at 4 weeks after start of first IVIg dose. The full range<br /><br>of scores will be considered as an ordinal outcome scale. In analyzing we will<br /><br>use a proportional odds model. (Extent of) improvement on this ordinal scale<br /><br>will be compared between groups.</p><br>
- Secondary Outcome Measures
Name Time Method