Recruiting NCT04871035
Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immunoadsorption, Plasma Exchange.
- Who it may be relevant to
- Registry conditions: GBS. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome.
Interventions
- Device Immunoadsorption
1 cycle, consisting of 5 sessions on 5 consecutive days with processing of the 0.7-fold individual plasma volume (maximum 2.5 l) each days with tryptophan adsorbers. - Device Plasma Exchange
1 cycle, consisting of 5 sessions on 5 consecutive days with exchange of 0.7-fold plasma volume (maximum 2.5 l) each day with albumin solution as volume replacement solution.
Primary outcome measures
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score [Time frame: 2 weeks]
- Inflammatory Neuropathy Cause and Treatment (INCAT) disability score [Time frame: 2 weeks]
- Oxford Muscle Strength Score (Medical Research Council, MRC) [Time frame: 2 weeks]
- Vibration Score [Time frame: 2 weeks]
Secondary outcome measures (12)
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score [Time frame: 1, 3, and 5 weeks]
- Inflammatory Neuropathy Cause and Treatment (INCAT) disability score [Time frame: 1, 3, and 5 weeks]
- Oxford Muscle Strength Score (Medical Research Council, MRC) [Time frame: 1, 3, and 5 weeks]
- Vibration Score [Time frame: 1, 3, and 5 weeks]
- Hughes Score [Time frame: 1, 2, 3, and 5 weeks]
- Pain [Time frame: 1, 2, 3, and 5 weeks]
- N20 [Time frame: 2 and 5 weeks]
- P40 [Time frame: 2 and 5 weeks]
- Nerve Conduction Velocity [Time frame: 2 and 5 weeks]
- Euro Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) [Time frame: 1, 2, 3, and 5 weeks]
- Immunoglobulin A in serum [Time frame: 1, 2, 3, and 5 weeks]
- Immunoglobulin A in cerebrospinal fluid (CSF) [Time frame: 2 weeks]
Eligibility criteria
Inclusion criteria
- Diagnosis of Guillain-Barré Syndrome according to the diagnostic criteria proposed by Doorn et al. (Clinical features, pathogenesis, and treatment of Guillain-Barré syndrome, Lancet neurology 2008)
- age 18 years or above
Exclusion criteria
- Clinical or laboratory (C-reactive protein 20 mg/l or above, or evidence of nitrite-positive urinary tract infection) evidence of manifest systemic infection
- Intake of angiotensin converting enzyme inhibitor within1 weeks before first treatment
- Other contraindications against immunoadsorption or plasma exchange
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Neurology, University of Ulm — Ulm
Identifiers
NCT: NCT04871035 · IPET-GBS 1.2