Plasma Exchange in Pediatric Autoimmune Encephalitis (PE/AIE)

July 12, 2026 updated by: Hani Hamed Saad, Menoufia University

Daily Versus Alternate-Day Plasma Exchange in Pediatric Autoimmune Encephalitis: A Randomized Controlled 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Nagwan Yossery Saleh, MD, pediatrics
  • Phone Number: +201003961071
  • Email: drnagwan80@gmail.com

Study Locations

  • Egypt
    • Menoufia Governorate
      • Shibīn al Kawm, Menoufia Governorate, Egypt
        • Menoufia university hospital, Pediatric intensive care unit
        • Sub-Investigator:
          • Nagwan Yossery Saleh, MD, pediatrics
        • Sub-Investigator:
          • Amira Zaki Badawy, MD, clinical pathology
        • Principal Investigator:
          • Hani Hamed Saad, MD, lecturer of pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A: Daily PLEX Group

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)
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
Active Comparator: Arm B : Alternate-Day PLEX Group
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to clinical improvement
Time Frame: 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.
Up to 90 days after randomization
Length of stay in the intensive care unit
Time Frame: 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.
Through ICU discharge (up to 90 days)
Total hospital length of stay
Time Frame: Through hospital discharge (up to 90 days)
Duration of hospitalization, measured in days from hospital admission until hospital discharge.
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
Number of participants experiencing plasma exchange-related adverse events, including hypotension, citrate toxicity, bleeding, catheter-related infection, catheter malfunction, allergic reactions, or transfusion reactions.
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
Death from any cause during the study follow-up period.
Up to 90 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Investigators

  • Principal Investigator: Hani Hamed Saad, MD, lecturer of pediatrics, Faculty of medicine, Menoufia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 12, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 12, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3/2026 PEDI 10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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