RecruitingNCT04871035
Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)
Sponsor
University of Ulm
Enrollment
20 participants
Start Date
Apr 28, 2021
Study Type
OBSERVATIONAL
Conditions
Summary
This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome.
Eligibility
Min Age: 18 Years
Inclusion Criteria2
- 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 Criteria3
- 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
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Interventions
DEVICEImmunoadsorption
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.
DEVICEPlasma 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04871035