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

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

Study Overview

• Status: Recruiting
• Conditions: GBS
• Intervention / Treatment: Device: Immunoadsorption; Device: Plasma Exchange

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Johannes Dorst, Prof; Phone Number: +49 731 177 5285; Email: johannes.dorst@uni-ulm.de

Study Locations

• Germany
  • Baden-Württemberg
    • Ulm, Baden-Württemberg, Germany, 89081
      • Recruiting
      • Department of Neurology, University of Ulm
      • Contact: Albert C Ludolph, MD, Prof.; Phone Number: 1200 +49-731-177-; Email: albert.ludolph@rku.de
      • Principal Investigator: Albert C Ludolph, MD, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Immunoadsorption	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.
Plasma Exchange	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 weeks
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score	Standard clinical score for inflammatory neuropathies.	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).	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).	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1, 3, and 5 weeks
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score	Standard clinical score for inflammatory neuropathies.	1, 3, and 5 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).	1, 3, and 5 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).	1, 3, and 5 weeks
Hughes Score	Standard clinical score to quantify disability in Guillain-Barré syndrome	1, 2, 3, and 5 weeks
Pain	Pain quantified on a visual analog scale between 0 (no pain) and 10 (maximum pain).	1, 2, 3, and 5 weeks
N20	N20 latency of nervus medianus (both sides) as measured by somatosensory evoked potentials (SEPs)	2 and 5 weeks
P40	P40 latency of nervus tibialis (both sides) as measured by somatosensory evoked potentials	2 and 5 weeks
Nerve Conduction Velocity	Nerve conduction velocity of clinically affected nerves as measured by electroneurography (ENG)	2 and 5 weeks
Euro Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)	Quality of Life Scale	1, 2, 3, and 5 weeks
Immunoglobulin A in serum	Immunoglobulin A serum concentration	1, 2, 3, and 5 weeks
Immunoglobulin A in cerebrospinal fluid (CSF)	Immunoglobulin A concentration in cerebrospinal fluid	2 weeks
Immunoglobulin G in serum	Immunoglobulin G serum concentration	1, 2, 3, and 5 weeks
Immunoglobulin G in cerebrospinal fluid (CSF)	Immunoglobulin G concentration in cerebrospinal fluid	2 weeks
Immunoglobulin M in serum	Immunoglobulin M serum concentration	1, 2, 3, and 5 weeks
Immunoglobulin M in cerebrospinal fluid (CSF)	Immunoglobulin M concentration in cerebrospinal fluid	2 weeks
Interleukin-1	Interleukin-1 serum concentration	1, 2, 3, and 5 weeks
Interleukin-6	Interleukin-6 serum concentration	1, 2, 3, and 5 weeks
Anti-GM1 antibodies	Anti-GM1 antibody serum levels	1, 2, 3, and 5 weeks
Anti-GQ1b	Anti-GQQ1b antibody serum levels	1, 2, 3, and 5 weeks
Neurofilament light chain (NfL) serum	Neurofilament light chain (NfL) serum levels	1, 2, 3, and 5 weeks
Neurofilament light chain (NfL) in cerebrospinal fluid (CSF)	Neurofilament light chain (NfL) levels in cerebrospinal fluid (CSF)	2 weeks
Safety and Tolerability	Kind and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)	1, 2, 3, and 5 weeks
Therapeutic Response	Share of patients with at least 20% improvement in CIDP score	1, 2, 3, and 5 weeks

Collaborators and Investigators

• Sponsor: University of Ulm
• Collaborators: DiaMed GmbH
• Investigators: Principal Investigator: Johannes Dorst, Prof, University of Ulm

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Anticipated): May 4, 2023
• Study Completion (Anticipated): May 4, 2023

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyradiculoneuropathy; Polyneuropathies; Guillain-Barre Syndrome
• Other Study ID Numbers: IPET-GBS 1.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, and figures), as well as the study protocol will be available. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at https://www.uniklinik-ulm.de/neurologie.html.
• IPD Sharing Time Frame: 3 months after publication until 5 years after publication
• IPD Sharing Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No