Plasma Exchange in Pediatric Autoimmune Encephalitis

NCT07707739 | Not Yet Recruiting DMC

• 1 other identifier: 3/2026 PEDI 10
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Encephalitis (AE)

Keywords

Plasma Exchange; Autoimmune Encephalitis; Pediatric; Randomized Controlled Trial

Outcome Measures

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.

  Within 24 hours after completion of the final plasma exchange session.

Secondary Outcomes (5)

• Time to clinical improvement

  Up to 90 days after randomization

• Length of stay in the intensive care unit

  Through ICU discharge (up to 90 days)

• Total hospital length of stay

  Through hospital discharge (up to 90 days)

• Incidence of plasma exchange-related adverse events

  From the first plasma exchange session until 7 days after the final plasma exchange session

• All-cause mortality

  Up to 90 days after randomization

Study Arms (2)

Arm A: Daily PLEX Group

ACTIVE COMPARATOR

This group (Arm A) will perform PLEX on consecutive days (e.g., Day 1, 2, 3, 4, 5) for 5 sessions; up to 7 sessions allowed. Intervention for Arm A: Plasma Exchange Procedure : 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.

Procedure: Plasma exchange (PE)

Arm B : Alternate-Day PLEX Group

ACTIVE COMPARATOR

This group ( Arm B) will perform PLEX every other day (e.g., Day 1, 3, 5, 7, 9) for 5 sessions; up to 7 sessions allowed.

Procedure: Plasma exchange (PE)

Interventions

Plasma exchange (PE) PROCEDURE

Plasma exchange (PE) sessions to be done daily for Arm A

Arm A: Daily PLEX Group; Arm B : Alternate-Day PLEX Group

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia university hospital, Pediatric intensive care unit

Shibīn al Kawm, Menoufia Governorate, Egypt

Location

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MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Hani Hamed Saad, MD, lecturer of pediatrics

  Faculty of medicine, Menoufia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hani Hamed Saad, MD, pediatrics

CONTACT

+201067610619; hani.hamed870@med.menofia.edu.eg

Nagwan Yossery Saleh, MD, Pediatrics

CONTACT

+201003961071; drnagwan80@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of pediatrics at Faculty of medicine , Menoufia university

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)