Plasma Exchange in Pediatric Autoimmune Encephalitis
ConditionAutoimmune Encephalitis (AE)
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Plasma exchange (PE)
Procedure/SurgeryPlasma exchange (PE) sessions to be done daily for Arm A
Plasma exchange (PE)
Procedure/SurgeryPlasma exchange (PE) sessions to be done on every other day for Arm B
Treatment groups
22 Participants
are divided into 2 treatment groupsGroup A: Arm A: Daily PLEX GroupActive comparator 1 intervention
Group B: Arm B : Alternate-Day PLEX GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Favorable functional outcome defined as modified Rankin Scale (mRS) score ≤ 2. The mRS will be assessed by a blinded assessor.
Modified Rankin Scale (mRS) score: Score Description Pediatric Adaptation 0 No symptoms. Age-appropriate functioning in all areas (motor, cognition, behavior). 1. No significant disability; able to carry out all usual activities despite symptoms. Mild behavioral or school-related issues but independent in daily activities. 2. Slight disability; unable to perform all previous activities but independent in self-care. Minor delays in school or play; needs extra time but no assistance in self-care. 3. Moderate disability; requires some help but can walk unassisted. Requires assistance in daily activities (feeding, dressing) but ambulant. 4. Moderately severe disability; unable to walk or attend to bodily needs without help. Dependent for most activities; may be wheelchair-bound but responsive. 5. Severe disability; bedridden, incontinent, requires constant nursing care. Completely dependent; may have profound cognitive or motor impairment. 6. Death. Death.
Time frame
Within 24 hours after completion of the final plasma exchange session.Secondary outcomes
1
Time to clinical improvement
Time from randomization to the first sustained improvement of at least one point on the modified Rankin Scale (mRS), maintained for at least 48 hours.
Time frame
Up to 90 days after randomization2
Length of stay in the intensive care unit
Duration of stay in the pediatric intensive care unit, measured in days from ICU admission until ICU discharge.
Time frame
Through ICU discharge (up to 90 days)3
Total hospital length of stay
Duration of hospitalization, measured in days from hospital admission until hospital discharge.
Time frame
Through hospital discharge (up to 90 days)4
Incidence of plasma exchange-related adverse events
Number of participants experiencing plasma exchange-related adverse events, including hypotension, citrate toxicity, bleeding, catheter-related infection, catheter malfunction, allergic reactions, or transfusion reactions.
Time frame
From the first plasma exchange session until 7 days after the final plasma exchange sessionSponsors and contacts
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Source ClinicalTrials.gov