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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma exchange (PE) | Procedure | Plasma exchange (PE) sessions to be done daily for Arm A |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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).
| Within 24 hours after completion of the final plasma exchange session. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 90 days after randomization |
| Length of stay in the intensive care unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hani Hamed Saad, MD, pediatrics | Contact | +201067610619 | hani.hamed870@med.menofia.edu.eg | |
| Nagwan Yossery Saleh, MD, Pediatrics | Contact | +201003961071 | drnagwan80@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hani Hamed Saad, MD, lecturer of pediatrics | Faculty of medicine, Menoufia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menoufia university hospital, Pediatric intensive care unit | Shibīn al Kawm | Menoufia Governorate | Egypt |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Related Info |
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| ID | Term |
|---|---|
| D020274 | Autoimmune Diseases of the Nervous System |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D010951 | Plasma Exchange |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D010956 | Plasmapheresis |
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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.
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| Plasma exchange (PE) | Procedure | Plasma exchange (PE) sessions to be done on every other day for Arm B |
|
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 | 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 | 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 | Death from any cause during the study follow-up period. | Up to 90 days after randomization |
| Related Info | View source |
| Related Info | View source |
| Related Info | View source |
| D001781 |
| Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |