Plasma Exchange in Pediatric Autoimmune Encephalitis
ConditionAutoimmune Encephalitis (AE)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorMenoufia University
About this trial
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
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Plasma exchange (PE)
- Plasma exchange (PE)
Treatment groups
22 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov