[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647345":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":33,"locations":43,"responsibleParty":63,"collaborators":24,"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":24,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":91,"whyStopped":24,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Menoufia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Daily PLEX Group","ACTIVE_COMPARATOR","This group (Arm A) will perform PLEX on consecutive days (e.g., Day 1, 2, 3, 4, 5) for 5 sessions; up to 7 sessions allowed.\n\nIntervention for Arm A:\n\nPlasma Exchange Procedure :\n\nA- Access: Central venous catheter (size appropriate for age and weight) or existing dialysis catheter.\n\nB- Exchange volume: 1-1.5 plasma volumes per session (age\u002Fweight-adjusted - typical formula: plasma volume = 0.07 × weight in kg × (1 - hematocrit)).\n\nC- Replacement fluid: 5% human albumin as first choice; fresh frozen plasma (FFP) may be used if clinically indicated (bleeding, coagulopathy), or combination as per local protocol.\n\nD- Anticoagulation: Regional citrate anticoagulation or systemic heparin according to institutional practice; monitor ionized calcium if citrate used.\n\nE- Monitoring: Vital signs pre-, intra-, and post-procedure; electrolytes, coagulation profile and calcium level as clinically indicated.",[13],"Procedure: Plasma exchange (PE)",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B : Alternate-Day PLEX Group","This group ( Arm B) will perform PLEX every other day (e.g., Day 1, 3, 5, 7, 9) for 5 sessions; up to 7 sessions allowed.",[13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Plasma exchange (PE)","Plasma exchange (PE) sessions to be done daily for Arm A",[9,15],null,{"type":20,"name":21,"description":26,"armGroupLabels":27,"otherNames":24},"Plasma exchange (PE) sessions to be done on every other day for Arm B",[9,15],[29],{"name":30,"affiliation":31,"role":32},"Hani Hamed Saad, MD, lecturer of pediatrics","Faculty of medicine, Menoufia University","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Hani Hamed Saad, MD, pediatrics","CONTACT","+201067610619","hani.hamed870@med.menofia.edu.eg",{"name":40,"role":36,"phone":41,"phoneExt":24,"email":42},"Nagwan Yossery Saleh, MD, Pediatrics","+201003961071","drnagwan80@gmail.com",[44],{"facility":45,"status":24,"city":46,"state":47,"zip":24,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Menoufia university hospital, Pediatric intensive care unit","Shibīn al Kawm","Menoufia Governorate","Egypt","EG",{"type":51,"coordinates":52},"Point",[53,54],31.00904,30.55258,{"lat":54,"lon":53},[57,58,61],{"name":30,"role":32,"phone":24,"phoneExt":24,"email":24},{"name":59,"role":60,"phone":24,"phoneExt":24,"email":24},"Nagwan Yossery Saleh, MD, pediatrics","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":24,"phoneExt":24,"email":24},"Amira Zaki Badawy, MD, clinical pathology",{"type":32,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Hani Hamed Saad","lecturer of pediatrics at Faculty of medicine , Menoufia university","100647345","plasma-exchange-in-pediatric-autoimmune-encephalitis-100647345",false,"NCT07707739","Plasma Exchange in Pediatric Autoimmune Encephalitis","Daily Versus Alternate-Day Plasma Exchange in Pediatric Autoimmune Encephalitis: A Randomized Controlled Trial","PE\u002FAIE","Inclusion Criteria:\n\n* Childern diagnosed as autoimmune encephalitis according to Cellucci et al., 2020; acute\u002Fsubacute onset (\\\u003C3 months) of encephalopathy with at least one of: new focal CNS findings, seizures, CSF pleocytosis, MRI suggestive of encephalitis, and supportive antibody testing when available.\n* Autoimmune encephalitis cases indicated clinically for PLEX as determined by the treating team (e.g., severe disease, refractory to steroids\u002FIVIG or as part of first-line combination therapy).\n\nExclusion Criteria:\n\n* Hemodynamic instability not amenable to plasma exchange.\n* Severe coagulopathy uncorrectable prior to PLEX (INR \\>2 despite correction, platelets \\\u003C50,000\u002FµL unless corrected).\n* Contraindications to central venous access placement.\n* Enrollment in another interventional trial that would interfere with the outcomes.","ALL","1 Month","18 Years",{"count":78,"type":79},22,"ESTIMATED","INTERVENTIONAL",[82],"NA","The aim of the study will be to compare the efficacy of daily plasma exchange (PLEX) versus alternate-day PLEX in achieving a favorable functional outcome in children with autoimmune encephalitis.\n\nThe study population will be divided into two groups, the first group will perform PLEX on consecutive days and the second one will perform it every other day. Then, A Favorable functional outcome measure defined as modified Rankin Scale (mRS) score ≤ 2. The mRS will be assessed by a blinded assessor at the end of the sessions to determine which method has superior efficacy in treatment of autoimmune encephalitis.",[85],"Autoimmune Encephalitis (AE)",[87,88,89,90],"Plasma Exchange","Autoimmune Encephalitis","Pediatric","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-07-12",{"date":94,"type":95},"2026-07-16","ACTUAL",{"date":97,"type":79},"2026-08-01",{"date":99,"type":79},"2027-03-31",{"name":5,"class":6},1]