Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)

University of Ulm20 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

GBS

Interventions

ImmunoadsorptionDEVICE

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.

Plasma ExchangeDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Neurology, University of Ulm

Ulm, Baden-Wurttemberg, Germany

RECRUITING

Outcomes

Primary Outcomes

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score

Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted

Time frame: 2 weeks

Inflammatory Neuropathy Cause and Treatment (INCAT) disability score

Standard clinical score for inflammatory neuropathies.

Time frame: 2 weeks

Oxford Muscle Strength Score (Medical Research Council, MRC)

Standard clinical score for evaluating muscle strength / paresis. Muscle strength will be measured on a scale between 0 (no movement) and 5 (full strength) on 8 pre-defined muscles (one proximal and one distal muscle at each extremity).

Time frame: 2 weeks

Vibration Score

Standard clinical score for evaluation of vibration sensitivity on a scale between 0 and 8, using a 256 tuning fork at 4 predefined spots (processus styloideus radii and malleolus lateralis on both sides).

Time frame: 2 weeks

Secondary Outcomes

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score

Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted

Time frame: 1, 3, and 5 weeks

Inflammatory Neuropathy Cause and Treatment (INCAT) disability score

Standard clinical score for inflammatory neuropathies.

Time frame: 1, 3, and 5 weeks

Oxford Muscle Strength Score (Medical Research Council, MRC)

Central Contacts

Johannes Dorst, Prof

CONTACT

+49 731 177 5285 johannes.dorst@uni-ulm.de

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 1, 3, and 5 weeks

Vibration Score

Time frame: 1, 3, and 5 weeks

Hughes Score

Standard clinical score to quantify disability in Guillain-Barré syndrome

Time frame: 1, 2, 3, and 5 weeks

Pain

Pain quantified on a visual analog scale between 0 (no pain) and 10 (maximum pain).

Time frame: 1, 2, 3, and 5 weeks

N20

N20 latency of nervus medianus (both sides) as measured by somatosensory evoked potentials (SEPs)

Time frame: 2 and 5 weeks

P40

P40 latency of nervus tibialis (both sides) as measured by somatosensory evoked potentials

Time frame: 2 and 5 weeks

Nerve Conduction Velocity

Nerve conduction velocity of clinically affected nerves as measured by electroneurography (ENG)

Time frame: 2 and 5 weeks

Euro Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)

Quality of Life Scale

Time frame: 1, 2, 3, and 5 weeks

Immunoglobulin A in serum

Immunoglobulin A serum concentration

Time frame: 1, 2, 3, and 5 weeks

Immunoglobulin A in cerebrospinal fluid (CSF)

Immunoglobulin A concentration in cerebrospinal fluid

Time frame: 2 weeks

Immunoglobulin G in serum

Immunoglobulin G serum concentration

Time frame: 1, 2, 3, and 5 weeks

Immunoglobulin G in cerebrospinal fluid (CSF)

Immunoglobulin G concentration in cerebrospinal fluid

Time frame: 2 weeks

Immunoglobulin M in serum

Immunoglobulin M serum concentration

Time frame: 1, 2, 3, and 5 weeks

Immunoglobulin M in cerebrospinal fluid (CSF)

Immunoglobulin M concentration in cerebrospinal fluid

Time frame: 2 weeks

Interleukin-1

Interleukin-1 serum concentration

Time frame: 1, 2, 3, and 5 weeks

Interleukin-6

Interleukin-6 serum concentration

Time frame: 1, 2, 3, and 5 weeks

Anti-GM1 antibodies

Anti-GM1 antibody serum levels

Time frame: 1, 2, 3, and 5 weeks

Anti-GQ1b

Anti-GQQ1b antibody serum levels

Time frame: 1, 2, 3, and 5 weeks

Neurofilament light chain (NfL) serum

Neurofilament light chain (NfL) serum levels

Time frame: 1, 2, 3, and 5 weeks

Neurofilament light chain (NfL) in cerebrospinal fluid (CSF)

Neurofilament light chain (NfL) levels in cerebrospinal fluid (CSF)

Time frame: 2 weeks

Safety and Tolerability

Kind and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: 1, 2, 3, and 5 weeks

Therapeutic Response

Share of patients with at least 20% improvement in CIDP score

Time frame: 1, 2, 3, and 5 weeks