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

NCT ID: NCT04871035

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-28

Study Completion Date

2025-05-04

Brief Summary

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

Detailed Description

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Conditions

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GBS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Immunoadsorption

Immunoadsorption

Intervention Type 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.

Plasma Exchange

Plasma Exchange

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DiaMed GmbH

INDUSTRY

Sponsor Role collaborator

University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Albert Christian Ludolph, Prof.

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johannes Dorst, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Ulm

Locations

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Department of Neurology, University of Ulm

Ulm, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Johannes Dorst, Prof

Role: CONTACT

+49 731 177 5285

Facility Contacts

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Albert C Ludolph, MD, Prof.

Role: primary

+49-731-177- ext. 1200

Other Identifiers

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IPET-GBS 1.2

Identifier Type: -

Identifier Source: org_study_id

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