Autoimmune Encephalitis (AE)PE/AIENCT07707739
Plasma Exchange in Pediatric Autoimmune Encephalitis
A study testing Plasma exchange (PE) in people with Autoimmune Encephalitis (AE), run by Menoufia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Autoimmune Encephalitis (AE)
- What is being tested?
- Plasma exchange (PE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Menoufia university hospital, Pediatric intensive care unit
Shibīn al Kawm, Menoufia Governorate
Hani Hamed Saad, MD, lecturer of pediatrics
Nagwan Yossery Saleh, MD, pediatrics
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Autoimmune Encephalitis (AE)
- Being tested
- Plasma exchange (PE)
- Keywords
- Plasma Exchange, Autoimmune Encephalitis, Pediatric, Randomized Controlled Trial
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma exchange (PE)Procedure or surgery
Plasma exchange (PE) sessions to be done daily for Arm A
Plasma exchange (PE)Procedure or surgery
Plasma exchange (PE) sessions to be done on every other day for Arm B
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Plasma exchange (PE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
- No significant disability; able to carry out all usual activities despite symptoms. Mild behavioral or school-related issues but independent in daily activities.
- 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.
- Moderate disability; requires some help but can walk unassisted. Requires assistance in daily activities (feeding, dressing) but ambulant.
- Moderately severe disability; unable to walk or attend to bodily needs without help. Dependent for most activities; may be wheelchair-bound but responsive.
- Severe disability; bedridden, incontinent, requires constant nursing care. Completely dependent; may have profound cognitive or motor impairment.
- Death. Death.
Measured: Within 24 hours after completion of the final plasma exchange session.
Secondary outcomes (5)
Time to clinical improvement
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.
Measured: Up to 90 days after randomization
Length of stay in the intensive care unit
Duration of stay in the pediatric intensive care unit, measured in days from ICU admission until ICU discharge.
Measured: Through ICU discharge (up to 90 days)
Total hospital length of stay
Duration of hospitalization, measured in days from hospital admission until hospital discharge.
Measured: Through hospital discharge (up to 90 days)
Incidence of plasma exchange-related adverse events
Number of participants experiencing plasma exchange-related adverse events, including hypotension, citrate toxicity, bleeding, catheter-related infection, catheter malfunction, allergic reactions, or transfusion reactions.
Measured: From the first plasma exchange session until 7 days after the final plasma exchange session
All-cause mortality
Death from any cause during the study follow-up period.
Measured: Up to 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Aug 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Encephalitis (AE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hani Hamed Saad, Menoufia University
- Investigators
- Hani Hamed Saad, MD, lecturer of pediatrics, Principal investigator, Faculty of medicine, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707739
- Sponsor's protocol ID
- 3/2026 PEDI 10
- Acronym
- PE/AIE
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Versus Alternate-Day Plasma Exchange in Pediatric Autoimmune Encephalitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07707739
- Acronym / sponsor ID
- PE/AIE / 3/2026 PEDI 10
- Conditions
- Autoimmune Encephalitis (AE)
- Keywords
- Plasma Exchange, Autoimmune Encephalitis, Pediatric, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A: Daily PLEX Group | Active comparator | Procedure: Plasma exchange (PE)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. |
| Arm B : Alternate-Day PLEX Group | Active comparator | Procedure: Plasma exchange (PE)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. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma exchange (PE)Plasma exchange (PE) sessions to be done daily for Arm A | Procedure or surgery | Arm A: Daily PLEX Group, Arm B : Alternate-Day PLEX Group |
| Plasma exchange (PE)Plasma exchange (PE) sessions to be done on every other day for Arm B | Procedure or surgery | Arm A: Daily PLEX Group, Arm B : Alternate-Day PLEX Group |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hani Hamed Saad, MD, lecturer of pediatrics principal investigator
Faculty of medicine, Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma exchange (PE) in people with Autoimmune Encephalitis (AE), run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hani Hamed Saad, MD, pediatrics (+201067610619, hani.hamed870@med.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.