Plasma Exchange in Pediatric Autoimmune Encephalitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Plasma exchange (PE), Plasma exchange (PE).
- Who it may be relevant to
- Registry conditions: Autoimmune Encephalitis (AE). Basic parameters: 1 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Daily Versus Alternate-Day Plasma Exchange in Pediatric Autoimmune Encephalitis: A Randomized Controlled Trial
Overview
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
- Procedure Plasma exchange (PE)
Plasma exchange (PE) sessions to be done daily for Arm A - Procedure Plasma exchange (PE)
Plasma exchange (PE) sessions to be done on every other day for Arm B
Primary outcome measures
- Favorable functional outcome defined as modified Rankin Scale (mRS) score ≤ 2. The mRS will be assessed by a blinded assessor. [Time frame: Within 24 hours after completion of the final plasma exchange session.]
Secondary outcome measures (5)
- Time to clinical improvement [Time frame: Up to 90 days after randomization]
- Length of stay in the intensive care unit [Time frame: Through ICU discharge (up to 90 days)]
- Total hospital length of stay [Time frame: Through hospital discharge (up to 90 days)]
- Incidence of plasma exchange-related adverse events [Time frame: From the first plasma exchange session until 7 days after the final plasma exchange session]
- All-cause mortality [Time frame: Up to 90 days after randomization]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Menoufia university hospital, Pediatric intensive care unit — Shibīn al Kawm
Identifiers
NCT: NCT07707739 · 3/2026 PEDI 10