NCT07707739 Plasma Exchange in Pediatric Autoimmune Encephalitis
| NCT ID | NCT07707739 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Menoufia University |
| Condition | Autoimmune Encephalitis (AE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2026-08-01 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 22 participants in total. It began in 2026-08-01 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The 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.
Eligibility Criteria
Inclusion Criteria: * Childern diagnosed as autoimmune encephalitis according to Cellucci et al., 2020; acute/subacute onset (\<3 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. * Autoimmune encephalitis cases indicated clinically for PLEX as determined by the treating team (e.g., severe disease, refractory to steroids/IVIG or as part of first-line combination therapy). Exclusion Criteria: * Hemodynamic instability not amenable to plasma exchange. * Severe coagulopathy uncorrectable prior to PLEX (INR \>2 despite correction, platelets \<50,000/µL unless corrected). * Contraindications to central venous access placement. * Enrollment in another interventional trial that would interfere with the outcomes.
Contact & Investigator
Hani Hamed Saad, MD, lecturer of pediatrics
PRINCIPAL INVESTIGATOR
Faculty of medicine, Menoufia University
Frequently Asked Questions
Who can join the NCT07707739 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 18 Years, studying Autoimmune Encephalitis (AE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07707739 currently recruiting?
Yes, NCT07707739 is actively recruiting participants. Contact the research team at hani.hamed870@med.menofia.edu.eg for enrollment information.
Where is the NCT07707739 trial being conducted?
This trial is being conducted at Shibīn al Kawm, Egypt.
Who is sponsoring the NCT07707739 clinical trial?
NCT07707739 is sponsored by Menoufia University. The principal investigator is Hani Hamed Saad, MD, lecturer of pediatrics at Faculty of medicine, Menoufia University. The trial plans to enroll 22 participants.