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Plasma Exchange in Pediatric Autoimmune Encephalitis (PE/AIE)

21 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

22

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Nagwan Yossery Saleh, MD, pediatrics
  • Número de teléfono: +201003961071
  • Correo electrónico: drnagwan80@gmail.com

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.
Procedimiento: Plasma exchange (PE)
Plasma exchange (PE) sessions to be done daily for Arm A
Procedimiento: Plasma exchange (PE)
Plasma exchange (PE) sessions to be done on every other day for Arm B
Comparador activo: 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.
Procedimiento: Plasma exchange (PE)
Plasma exchange (PE) sessions to be done daily for Arm A
Procedimiento: Plasma exchange (PE)
Plasma exchange (PE) sessions to be done on every other day for Arm B

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Favorable functional outcome defined as modified Rankin Scale (mRS) score ≤ 2. The mRS will be assessed by a blinded assessor.
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to clinical improvement
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Up to 90 days after randomization
Death from any cause during the study follow-up period.
Up to 90 days after randomization

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Menoufia University

Investigadores

  • Investigador principal: Hani Hamed Saad, MD, lecturer of pediatrics, Faculty of medicine, Menoufia University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

28 de febrero de 2027

Finalización del estudio (Estimado)

31 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

1 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

12 de julio de 2026

Publicado por primera vez (Actual)

16 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de agosto de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 3/2026 PEDI 10

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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