Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)
ConditionGBS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Ulm
About this trial
This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Immunoadsorption
Device1 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
Device1 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Immunoadsorption1 intervention
Group B: Plasma Exchange1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
Standard clinical score for inflammatory neuropathies.
Time frame
2 weeks3
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 weeks4
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 weeksSecondary outcomes
1
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 weeks2
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
Standard clinical score for inflammatory neuropathies.
Time frame
1, 3, and 5 weeks3
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
1, 3, and 5 weeks4
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
1, 3, and 5 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Ulm
Lead sponsor
DiaMed GmbH
Collaborator
Source ClinicalTrials.gov