Plasma Exchange in Pediatric Autoimmune Encephalitis
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Plasma exchange (PE), Plasma exchange (PE).
- Кому может быть актуально
- Состояния в реестре: Autoimmune Encephalitis (AE). Базовые параметры: 1 мес. — 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Daily Versus Alternate-Day Plasma Exchange in Pediatric Autoimmune Encephalitis: A Randomized Controlled Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Процедура Plasma exchange (PE)
Plasma exchange (PE) sessions to be done daily for Arm A - Процедура Plasma exchange (PE)
Plasma exchange (PE) sessions to be done on every other day for Arm B
Первичные конечные точки
- Favorable functional outcome defined as modified Rankin Scale (mRS) score ≤ 2. The mRS will be assessed by a blinded assessor. [Срок оценки: Within 24 hours after completion of the final plasma exchange session.]
Вторичные конечные точки (5)
- Time to clinical improvement [Срок оценки: Up to 90 days after randomization]
- Length of stay in the intensive care unit [Срок оценки: Through ICU discharge (up to 90 days)]
- Total hospital length of stay [Срок оценки: Through hospital discharge (up to 90 days)]
- Incidence of plasma exchange-related adverse events [Срок оценки: From the first plasma exchange session until 7 days after the final plasma exchange session]
- All-cause mortality [Срок оценки: Up to 90 days after randomization]
Критерии участия
Критерии включения
- 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).
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Египет · 1 центр
- Menoufia university hospital, Pediatric intensive care unit — Shibīn al Kawm
Идентификаторы
NCT: NCT07707739 · 3/2026 PEDI 10