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

NCT04871035 | Recruiting

• 1 other identifier: IPET-GBS 1.2
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

GBS

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (24)

• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score

  1, 3, and 5 weeks

• Inflammatory Neuropathy Cause and Treatment (INCAT) disability score

  1, 3, and 5 weeks

• Oxford Muscle Strength Score (Medical Research Council, MRC)

  1, 3, and 5 weeks

• Vibration Score

  1, 3, and 5 weeks

• Hughes Score

  1, 2, 3, and 5 weeks

Study Arms (2)

Immunoadsorption

Device: Immunoadsorption

Plasma Exchange

Device: Plasma Exchange

Interventions

Immunoadsorption DEVICE

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.

Immunoadsorption

Plasma Exchange DEVICE

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.

Plasma Exchange

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DiaMed GmbH: collaborator
• University of Ulm: lead

Study Sites (1)

Department of Neurology, University of Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

MeSH Terms

Interventions

Plasmapheresis; Plasma Exchange

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative; Blood Transfusion; Biological Therapy

Study Officials

• Johannes Dorst, Prof

  University of Ulm

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Dorst, Prof

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 4, 2021
• Study Start: April 28, 2021
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 months after publication until 5 years after publication
• 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.

Locations

DE (1)