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| Name | Class |
|---|---|
| DiaMed GmbH | INDUSTRY |
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This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunoadsorption |
| ||
| Plasma Exchange |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johannes Dorst, Prof | Contact | +49 731 177 5285 | johannes.dorst@uni-ulm.de |
| Name | Affiliation | Role |
|---|---|---|
| Johannes Dorst, Prof | University of Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, University of Ulm | Recruiting | Ulm | Baden-Wurttemberg | 89081 | Germany |
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.
3 months after publication until 5 years after 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.
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| ID | Term |
|---|---|
| D010956 | Plasmapheresis |
| D010951 | Plasma Exchange |
| ID | Term |
|---|---|
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
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| 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. |
|
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 |
| D013514 | Surgical Procedures, Operative |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |