[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100448091":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":41,"locations":46,"responsibleParty":63,"collaborators":33,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":33,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":88,"whyStopped":33,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"The First Affiliated Hospital of Zhengzhou University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immunoadsorption group","EXPERIMENTAL","Protein A immunoadsorption therapy",[13],"Device: immunosorbent column",{"label":15,"type":16,"description":17,"interventionNames":18},"intravenous immunoglobulin group","ACTIVE_COMPARATOR","Treatment with intravenous immunoglobulin",[19],"Drug: intravenous immunoglobulin",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","immunosorbent column","Immunoadsorption treatment regimen: the treatment is performed once every 1-3 days, at least 5 times, and the amount of regenerated plasma for each treatment is 1 to 3 times the plasma volume. The immunosorbent column adopts the protein A immunosorbent column.",[9],[27],"Protein A Immunoadsorption",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","intravenous immunoglobulin","Intravenous immunoglobulin treatment regimen: intravenous immunoglobulin therapy, 400mg\u002Fkg\u002Fd, once a day, for at least 5 consecutive days.",[15],null,[35,38],{"name":36,"affiliation":5,"role":37},"Junfang Teng, Prof","STUDY_DIRECTOR",{"name":39,"affiliation":5,"role":40},"Wang Miao, Prof","PRINCIPAL_INVESTIGATOR",[42],{"name":39,"role":43,"phone":44,"phoneExt":33,"email":45},"CONTACT","0086-13592567185","miaowang7211@126.com",[47],{"facility":48,"status":33,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"First Affiliated Hospital of Zhengzhou University","Zhengzhou","Henan","450052","China","CN",{"type":55,"coordinates":56},"Point",[57,58],113.64861,34.75778,{"lat":58,"lon":57},[61,62],{"name":39,"role":43,"phone":33,"phoneExt":33,"email":33},{"name":39,"role":40,"phone":33,"phoneExt":33,"email":33},{"type":40,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Wang Miao","professor","100448091","comparison-of-the-efficacy-and-safety-of-immunoadsorption-and-intravenous-immunoglobulin-for-guillain-barre-syndrome-100448091",false,"NCT05114941","Comparison of the Efficacy and Safety of Immunoadsorption and Intravenous Immunoglobulin for Guillain-Barre Syndrome","A Prospective, Multi-center, Randomized Parallel Controlled Clinical Study on the Efficacy and Safety of Protein A Immunoadsorption and Intravenous Immunoglobulin in the Treatment of Guillain-Barre Syndrome","GBS-PRAISING","Inclusion Criteria:\n\n1. Meet the diagnostic criteria of Guillain - Barre syndrome;\n2. The onset is within 2 weeks;\n3. Age is greater than or equal to 18 years old and less than or equal to 60 years old;\n4. Hughes function classification is greater than or equal to 3;\n5. The subject or his legal representative can understand the purpose of the research, show sufficient compliance with the research protocol, and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Those who are pregnant;\n2. Three months before the screening period, receive immunoadsorption therapy or intravenous immunoglobulin therapy;\n3. Those who have a history of allergies in the membrane of the plasma separator;\n4. Those who must use angiotensin-converting enzyme inhibitor drugs within 1 week before being included in the trial and during treatment and cannot be stopped;\n5. Severe active bleeding or diffuse intravascular coagulation, patients with systemic circulatory failure that are difficult to correct with drugs;\n6. Severe cardiac insufficiency, that is, those who have reached NYHA IV according to the heart failure classification standards of the New York Heart Association (NYHA);\n7. There are contraindications to intravenous immunoglobulin;\n8. Those with other system autoimmune diseases;\n9. Diagnosis of variant GBS: such as Miller-Fisher syndrome, GBS with cranial nerve damage, sensory GBS, pan-autonomous GBS. Patients with chronic inflammatory demyelinating polyperipheral neuropathy whose condition has been significantly alleviated when visiting a doctor;\n10. Subjects who have participated in any other drug or medical device clinical trials within 1 month before entering the screening period; Note: Subjects who participated in observational studies (that is, the study does not require changes or other interventions) will not be excluded;\n11. Patients who cannot obtain informed consent;\n12. Those who cannot receive active and comprehensive treatment.","ALL","18 Years","60 Years",{"count":78,"type":79},204,"ESTIMATED","INTERVENTIONAL",[82],"NA","Guillain-Barre syndrome is an immune-mediated acute inflammatory peripheral neuropathy. The currently effective treatment methods include intravenous immunoglobulin and plasma exchange. Immunoadsorption has been widely used to treat immune-related diseases. There are currently no prospective large-sample clinical trials of immunoadsorption therapy for Guillain-Barre syndrome. The neuro-intensive care unit of the First Affiliated Hospital of Zhengzhou University is preparing to carry out a prospective, multi-center, randomized parallel controlled clinical study on the efficacy and safety of protein A immunoadsorption and intravenous immunoglobulin (IVIG) in the treatment of Guillain-Barre syndrome. It is estimated that 204 patients with Guillain-Barre syndrome will be included. The patients will be randomly assigned to the immunoadsorption group and the IVIG group. The primary outcome measure: changes in Hughes scores (4 weeks after starting treatment vs. baseline (before starting treatment) ). This study aims to explore the efficacy and safety of protein A immunoadsorption and intravenous immunoglobulin in the treatment of Guillain-Barre syndrome.",[85],"Guillain-Barre Syndrome",[87,30],"immunoadsorption","NOT_YET_RECRUITING","2025-03-10",{"date":91,"type":92},"2025-03-12","ACTUAL",{"date":94,"type":79},"2026-01-01",{"date":96,"type":79},"2026-12-31",{"name":5,"class":6},1]