International Second Immunoglobulin Dose in Guillain-Barré Syndrome patients with poor prognosis. NO LONGER A SEPARATE STUDY. THIS STUDY WILL BELONG TO THE IGOS STUDY (NTR 3290).

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24041

Enrollment

300

Registered

2012-02-13

Start date

2012-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Guillain-Barré syndrome

Interventions

None listed

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: To enter this GBS study: 1. Age less than 6 years; 2. Patient known to have a severe allergic reaction to properly matched blood products or plasma products; 3. Pregnancy or breastfeeding; 4. Patient known to have a selective IgA deficiency; 5. Patient shows clear clinical evidence of a polyneuropathy caused by e.g. diabetes mellitus (except mild sensory), alcoholism, severe vitamin deficiency, and porphyria; 6. Patient received immunosuppressive treatment (e.g. azathioprine, cyclosporine, mycofenolatemofetil, tacrolimus, sirolimus or > 20 mg prednisolon daily) during the last month; 7. Patient known to have a severe concurrent disease, like malignancy, severe cardiovascular disease, AIDS, severe COPD; 8. Inability to attend follow-up during 6 months.

Design outcomes

Primary

Measure	Time frame
To determine whether a second IVIg course in GBS patients with a poor prognosis (mEGOS 6-12) improves functional outcome after 4 weeks.	—

Secondary

Measure	Time frame
To investigate whether a second IVIg course in GBS patients with a poor prognosis: 1. Improves functional outcome or muscle strength after 8, 12 and 26 weeks; 2. Lowers the percentage of patients requiring assisted ventilation, reduces the duration (number of days) on a ventilator or days in the intensive care unit; 3. Reduces the time (days) to hospital discharge; 4. Reduces the frequency of secondary deterioration due to treatment-related fluctuations (TRF); 5. Increases the frequency of treatment related complications; 6. Reduces GBS-related mortality; 7. Increases serum IgG further (and to what extent) and assess any relationship to IgG level after second IVIg dose and outcome. To investigate whether: 1. Serum IgG increase after the first IVIg dose is lower in patients with a poor prognosis.	—

Measure

Time frame

To investigate whether a second IVIg course in GBS patients with a poor prognosis: 1. Improves functional outcome or muscle strength after 8, 12 and 26 weeks; 2. Lowers the percentage of patients requiring assisted ventilation, reduces the duration (number of days) on a ventilator or days in the intensive care unit; 3. Reduces the time (days) to hospital discharge; 4. Reduces the frequency of secondary deterioration due to treatment-related fluctuations (TRF); 5. Increases the frequency of treatment related complications; 6. Reduces GBS-related mortality; 7. Increases serum IgG further (and to what extent) and assess any relationship to IgG level after second IVIg dose and outcome. To investigate whether: 1. Serum IgG increase after the first IVIg dose is lower in patients with a poor prognosis.

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Contacts

Public ContactBianca Berg, van den

ErasmusMC University Medical Center Dr. Molewaterplein 50, room Ee2230 PO box 2040

b.vandenberg.2@erasmusmc.nl-

Outcome results