Comparison of the Efficacy and Safety of Immunoadsorption and Intravenous Immunoglobulin for Guillain-Barre Syndrome
- Conditions
- Guillain-Barre Syndrome
- Registration Number
- NCT05114941
- Lead Sponsor
- The First Affiliated Hospital of Zhengzhou University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 204
Inclusion Criteria:<br><br> 1. Meet the diagnostic criteria of Guillain - Barre syndrome;<br><br> 2. The onset is within 2 weeks;<br><br> 3. Age is greater than or equal to 18 years old and less than or equal to 60 years old;<br><br> 4. Hughes function classification is greater than or equal to 3;<br><br> 5. The subject or his legal representative can understand the purpose of the research,<br> show sufficient compliance with the research protocol, and sign an informed consent<br> form.<br><br>Exclusion Criteria:<br><br> 1. Those who are pregnant;<br><br> 2. Three months before the screening period, receive immunoadsorption therapy or<br> intravenous immunoglobulin therapy;<br><br> 3. Those who have a history of allergies in the membrane of the plasma separator;<br><br> 4. Those who must use angiotensin-converting enzyme inhibitor drugs within 1 week<br> before being included in the trial and during treatment and cannot be stopped;<br><br> 5. Severe active bleeding or diffuse intravascular coagulation, patients with systemic<br> circulatory failure that are difficult to correct with drugs;<br><br> 6. Severe cardiac insufficiency, that is, those who have reached NYHA IV according to<br> the heart failure classification standards of the New York Heart Association (NYHA);<br><br> 7. There are contraindications to intravenous immunoglobulin;<br><br> 8. Those with other system autoimmune diseases;<br><br> 9. Diagnosis of variant GBS: such as Miller-Fisher syndrome, GBS with cranial nerve<br> damage, sensory GBS, pan-autonomous GBS. Patients with chronic inflammatory<br> demyelinating polyperipheral neuropathy whose condition has been significantly<br> alleviated when visiting a doctor;<br><br> 10. Subjects who have participated in any other drug or medical device clinical trials<br> within 1 month before entering the screening period; Note: Subjects who participated<br> in observational studies (that is, the study does not require changes or other<br> interventions) will not be excluded;<br><br> 11. Patients who cannot obtain informed consent;<br><br> 12. Those who cannot receive active and comprehensive treatment.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in Hughes scores
- Secondary Outcome Measures
Name Time Method Changes in Hughes scores;Reached Hughes Grade 2;Ventilator application time;Total time in ICU;Changes of total lymphocyte count, interleukin-6, interleukin-8, cerebrospinal fluid protein;Changes of Compound muscle action potential and motor nerve conduction velocity of bilateral tibial nerves