Autoimmune Encephalitis (AE)
Conditions
Keywords
Plasma Exchange, Autoimmune Encephalitis, Pediatric, Randomized Controlled Trial
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.
Detailed description
This will be a Prospective, randomized, open- label, parallel-group, center trial, which will include enough number of children admitted at Pediatric Intensive Care Unit (PICU) of Menoufia university Hospital with autoimmune encephalitis from August 2026 to February 2027. Grouping : The study population will be divided into two groups: 1. Daily PLEX Group (Arm A): This group will perform PLEX on consecutive days (e.g., Day 1, 2, 3, 4, 5) for 5 sessions; up to 7 sessions allowed. 2. Alternate-Day PLEX Group (Arm B): This group will perform PLEX every other day (e.g., Day 1, 3, 5, 7, 9) for 5 sessions; up to 7 sessions allowed. All patients in this study will be subjected to: A- Demographic and clinical data Collection: * Patient demographics: age, sex, Wt., Ht., and body mass index (BMI). * PLEX parameters: date/time of each session, exchanged volume, replacement fluid, anticoagulation used and immediate complications if any. B- Full clinical examination will be done including vital signs (HR, RR, BP, temperature), Pediatric Glasgow Coma Scale to assess consciousness level and neurological examination. C- Investigations will be done including the following: Laboratory Analysis: CBC, CRP, Electrolytes, calcium level, blood culture, urea, creatinine, ALT, AST, procalcitonin, coagulation profile and D-dimer level. Radiological: Chest X ray, Brain CT, MRI and EEG if they needed. Intervention and Monitoring Plasma Exchange Procedure (both arms): A- Access: Central venous catheter (size appropriate for age and weight) or existing dialysis catheter. B- Exchange volume: 1-1.5 plasma volumes per session (age/weight-adjusted - typical formula: plasma volume = 0.07 × weight in kg × (1 - hematocrit)). C- 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. D- Anticoagulation: Regional citrate anticoagulation or systemic heparin according to institutional practice; monitor ionized calcium if citrate used. E- Monitoring: Vital signs pre-, intra-, and post-procedure; electrolytes, coagulation profile and calcium level as clinically indicated. F- Number of sessions: Up to 5 sessions recommended; clinicians may extend to 7 sessions if inadequate clinical response.
Interventions
PROCEDUREPlasma exchange (PE)
Plasma exchange (PE) sessions to be done daily for Arm A
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study population will be divided into two groups( two arms) , the first group will perform PLEX on consecutive days and the second one will perform it every other day.
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Favorable functional outcome defined as modified Rankin Scale (mRS) score ≤ 2. The mRS will be assessed by a blinded assessor. | Within 24 hours after completion of the final plasma exchange session. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to clinical improvement | Up to 90 days after randomization | 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. |
| Length of stay in the intensive care unit | Through ICU discharge (up to 90 days) | Duration of stay in the pediatric intensive care unit, measured in days from ICU admission until ICU discharge. |
| Total hospital length of stay | Through hospital discharge (up to 90 days) | Duration of hospitalization, measured in days from hospital admission until hospital discharge. |
| Incidence of plasma exchange-related adverse events | From the first plasma exchange session until 7 days after the final plasma exchange session | Number of participants experiencing plasma exchange-related adverse events, including hypotension, citrate toxicity, bleeding, catheter-related infection, catheter malfunction, allergic reactions, or transfusion reactions. |
| All-cause mortality | Up to 90 days after randomization | Death from any cause during the study follow-up period. |
Countries
Egypt
Contacts
CONTACTHani Hamed Saad, MD, pediatrics
CONTACTNagwan Yossery Saleh, MD, Pediatrics
PRINCIPAL_INVESTIGATORHani Hamed Saad, MD, lecturer of pediatrics
Faculty of medicine, Menoufia University
Outcome results
None listed