ClinicalTrials.gov record NCT07707739

Plasma Exchange in Pediatric Autoimmune Encephalitis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
AgeUnder 1 month old to 18 years old
SexAll
LocationEgypt
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized trial compares two plasma exchange (PLEX) schedules in children with autoimmune encephalitis: consecutive-day PLEX versus every-other-day PLEX. Each arm is planned for five sessions (clinicians may extend to seven). The main outcome is functional status measured by the modified Rankin Scale (mRS) by a blinded assessor within 24 hours after the final PLEX. The study is open-label and participants are assigned randomly to one of two parallel groups.

What it is studying. Whether performing plasma exchange on consecutive days or on alternate days leads to different functional outcomes (measured by mRS) in children with autoimmune encephalitis.

What the researchers hope to learn. To compare daily versus alternate-day plasma exchange for achieving a favorable functional outcome (mRS ≤ 2). Secondary goals include measuring time to clinical improvement, ICU and total hospital length of stay, incidence of PLEX-related adverse events, and all-cause mortality.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Procedure
  • Plasma exchange (PE)

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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:

  • 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.

  • 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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomly assigned to receive plasma exchange on consecutive days or every other day. Plasma exchange requires a central venous catheter (a tube placed into a large vein) and typically involves five sessions (clinicians may extend up to seven). Each session exchanges about 1–1.5 plasma volumes, uses 5% albumin or fresh frozen plasma for replacement as needed, and involves anticoagulation (regional citrate or systemic heparin) with monitoring of vital signs and relevant blood tests. The study team will record clinical exams (including Pediatric Glasgow Coma Scale), lab results, procedure details and any complications, assess functional outcome with the modified Rankin Scale within 24 hours after the final session, and follow clinical outcomes (time to improvement, ICU and hospital length of stay, procedure-related adverse events, and survival) for up to 90 days.

How the study is structured. A randomized, open-label (not masked), parallel-group trial: children are assigned to either daily PLEX or alternate-day PLEX, receive up to five sessions (up to seven if extended), and are followed through their PLEX course with outcomes assessed by a blinded evaluator.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in Egypt. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on autoimmune encephalitis

Clinical trials40 trials listed for autoimmune encephalitisEvery trial the registry lists for autoimmune encephalitis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in autoimmune encephalitis researchLatest monthly update: September 2026. Includes: Efgartigimod reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Aug 1, 2026
Primary completion
Feb 28, 2027 (estimated)
Study completion
Mar 31, 2027 (estimated)
Target enrollment
22 participants (estimated)
Last updated on registry
Oct 7, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Menoufia University
Principal investigator
Hani Hamed Saad, lecturer of pediatrics at Faculty of medicine , Menoufia university
Menoufia University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Menoufia university hospital, Pediatric intensive care unitRecruiting

    Shibīn al Kawm, Menoufia Governorate · Egypt

    • Hani Hamed Saad, MD, lecturer of pediatrics
    • Nagwan Yossery Saleh, MD, pediatrics
    • Amira Zaki Badawy, MD, clinical pathology

Terms used on this page · explanations by MedicalUpdates.ai

outcome measure
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
blinded
Who does not know which intervention a participant is receiving. It can apply to participants, the people giving the treatment, those assessing results, or those analysing the data.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
Contraindications
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
parallel-group
Participants are divided into two or more groups, and each group receives a different intervention at the same time, so the groups can be compared.
CT
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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