Clinical trial NCT04871035: Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)
Official title: Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GBS
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: DiaMed GmbH
First posted: 2021-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients diagnosed with Guillain-Barré syndrome (GBS) who are treated with either plasma exchange or immunoadsorption in the Department of Neurology, University of Ulm.

Brief summary: This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome.


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

Primary outcomes:
measure: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score
timeFrame: 2 weeks
measure: Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
timeFrame: 2 weeks
measure: Oxford Muscle Strength Score (Medical Research Council, MRC)
timeFrame: 2 weeks
measure: Vibration Score
timeFrame: 2 weeks
Secondary outcomes:
measure: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score
timeFrame: 1, 3, and 5 weeks
measure: Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
timeFrame: 1, 3, and 5 weeks
measure: Oxford Muscle Strength Score (Medical Research Council, MRC)
timeFrame: 1, 3, and 5 weeks
measure: Vibration Score
timeFrame: 1, 3, and 5 weeks
measure: Hughes Score
timeFrame: 1, 2, 3, and 5 weeks
measure: Pain
timeFrame: 1, 2, 3, and 5 weeks
measure: N20
timeFrame: 2 and 5 weeks
measure: P40
timeFrame: 2 and 5 weeks
measure: Nerve Conduction Velocity
timeFrame: 2 and 5 weeks
measure: Euro Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)
timeFrame: 1, 2, 3, and 5 weeks
measure: Immunoglobulin A in serum
timeFrame: 1, 2, 3, and 5 weeks
measure: Immunoglobulin A in cerebrospinal fluid (CSF)
timeFrame: 2 weeks
measure: Immunoglobulin G in serum
timeFrame: 1, 2, 3, and 5 weeks
measure: Immunoglobulin G in cerebrospinal fluid (CSF)
timeFrame: 2 weeks
measure: Immunoglobulin M in serum
timeFrame: 1, 2, 3, and 5 weeks
measure: Immunoglobulin M in cerebrospinal fluid (CSF)
timeFrame: 2 weeks
measure: Interleukin-1
timeFrame: 1, 2, 3, and 5 weeks
measure: Interleukin-6
timeFrame: 1, 2, 3, and 5 weeks
measure: Anti-GM1 antibodies
timeFrame: 1, 2, 3, and 5 weeks
measure: Anti-GQ1b
timeFrame: 1, 2, 3, and 5 weeks
measure: Neurofilament light chain (NfL) serum
timeFrame: 1, 2, 3, and 5 weeks
measure: Neurofilament light chain (NfL) in cerebrospinal fluid (CSF)
timeFrame: 2 weeks
measure: Safety and Tolerability
timeFrame: 1, 2, 3, and 5 weeks
measure: Therapeutic Response
timeFrame: 1, 2, 3, and 5 weeks
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Department of Neurology, University of Ulm
state: Baden-Württemberg
Study officials:
affiliation: University of Ulm
name: Johannes Dorst, Prof
role: PRINCIPAL_INVESTIGATOR
References: