Plasma Exchange in Pediatric Autoimmune Encephalitis (PE/AIE)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Hani Hamed Saad, MD, pediatrics
- 電話番号：+201067610619
- メール：hani.hamed870@med.menofia.edu.eg
研究連絡先のバックアップ
- 名前：Nagwan Yossery Saleh, MD, pediatrics
- 電話番号：+201003961071
- メール：drnagwan80@gmail.com
研究場所
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Menoufia Governorate
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Shibīn al Kawm、Menoufia Governorate、エジプト
- 募集
- Menoufia university hospital, Pediatric intensive care unit
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副調査官：
- Nagwan Yossery Saleh, MD, pediatrics
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副調査官：
- Amira Zaki Badawy, MD, clinical pathology
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主任研究者：
- Hani Hamed Saad, MD, lecturer of pediatrics
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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. |
Plasma exchange (PE) sessions to be done daily for Arm A
Plasma exchange (PE) sessions to be done on every other day for Arm B
|
|
アクティブコンパレータ：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.
|
Plasma exchange (PE) sessions to be done daily for Arm A
Plasma exchange (PE) sessions to be done on every other day for Arm B
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Favorable functional outcome defined as modified Rankin Scale (mRS) score ≤ 2. The mRS will be assessed by a blinded assessor.
時間枠：Within 24 hours after completion of the final plasma exchange session.
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Modified Rankin Scale (mRS) score: Score Description Pediatric Adaptation 0 No symptoms. Age-appropriate functioning in all areas (motor, cognition, behavior).
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Within 24 hours after completion of the final plasma exchange session.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time to clinical improvement
時間枠：Up to 90 days after randomization
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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.
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Up to 90 days after randomization
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Length of stay in the intensive care unit
時間枠：Through ICU discharge (up to 90 days)
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Duration of stay in the pediatric intensive care unit, measured in days from ICU admission until ICU discharge.
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Through ICU discharge (up to 90 days)
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Total hospital length of stay
時間枠：Through hospital discharge (up to 90 days)
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Duration of hospitalization, measured in days from hospital admission until hospital discharge.
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Through hospital discharge (up to 90 days)
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Incidence of plasma exchange-related adverse events
時間枠：From the first plasma exchange session until 7 days after the final plasma exchange session
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Number of participants experiencing plasma exchange-related adverse events, including hypotension, citrate toxicity, bleeding, catheter-related infection, catheter malfunction, allergic reactions, or transfusion reactions.
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From the first plasma exchange session until 7 days after the final plasma exchange session
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All-cause mortality
時間枠：Up to 90 days after randomization
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Death from any cause during the study follow-up period.
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Up to 90 days after randomization
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Hani Hamed Saad, MD, lecturer of pediatrics、Faculty of medicine, Menoufia University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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