Efficacy and Tolerance of Therapeutic Apheresis in Paediatric Neurology: a French Multicenter Study

Study Overview
=================
Brief Summary
-----------------
After developing in pediatric hematology and nephrology, therapeutic apheresis is increasingly used in pediatric neurology despite a sparse level of evidence. There are a few retrospective series with a small number of patients, concerning mainly autoimmune diseases (encephalitis, myasthenia gravis, polyradiculoneuritis). The objective of this work is to study therapeutic apheresis (including plasma exchange and immunoadsorption) among french neuropediatric tertiary centers and to prove that this treatment modality is effective and well tolerated in pediatric neurology diseases.

Detailed Description
-----------------
Multicenter medical data collection : Montpellier Toulouse Bordeaux Marseille Nancy Paris Kremlin Bicêtre Paris Robert Debré Paris Necker Paris Trousseau Lyon Besançon Rennes Reims Strasbourg La Réunion Nantes Tours

Official Title
-----------------
Efficacy and Tolerance of Therapeutic Apheresis in Paediatric Neurology: a Retrospective French Multicenter Study

Conditions
-----------------
Apheresis Related Complication

Intervention / Treatment
-----------------
* Other: Efficacy of apheresis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Children under 18. Supported in a participating CHU between 2014 and 2019. Having benefited from therapeutic apheresis (plasma exchanges and immunoadsorption) in a neuropediatric indication Exclusion criteria: - Family or patient refusal to participate

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| plasma exchange<br>All patients underwent plasma exchanges between 2014 and 2019 for a neuropediatric pathology | Other: Efficacy of apheresis<br>* Efficacy of apheresis<br>|
| immunoadsorption<br>All patients who underwent immunoadsorptions between 2014 and 2019 for a neuropediatric pathology | Other: Efficacy of apheresis<br>* Efficacy of apheresis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global neurological efficacy of therapeutic apheresis as assessed | lobal neurological efficacy of therapeutic apheresis as assessed by modified rankin score Modifed Rankin score, ranging from 0 (no symptoms) to 6 (death) | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of therapeutic apheresis adverse events as assessed | tIncidence of therapeutic apheresis adverse events as assessed by low blood tension rate, transfusion rate, infection rate, hypocalcaemia rate, thrombosis rate, allergy rate, anemia rate, hemostasis disorders rate). | through study completion, an average of 2 years | 
| Incidence of adjuvant treatments | Incidence of adjuvant treatments (corticosteroid therapy, immunoglobulins, immunosuppressants), | through study completion, an average of 2 years | 
| Incidence of hospitalization in intensive care | Incidence of hospitalization in intensive care, intubation rate | through study completion, an average of 2 years | 
| Description of the therapeutic apharesis modalities | number of procedures | through study completion, an average of 2 years | 
| Description of the therapeutic apharesis modalities | exchanged volume (in plasma volume percentage) for each procedure | through study completion, an average of 2 years | 
| Description of the therapeutic apharesis modalities | type of separation et number of participants with ttt-related advesre events | through study completion, an average of 2 years | 
| Description of the therapeutic apharesis modalities | type of replacement solution (isotonic saline, albumin, fresh frozen plasma) | through study completion, an average of 2 years | 
| Number of participitants with treatment-related adverse events | rate of arterial hypotension (< age standards and and requiring isotonic saline bolus, for each patient and for procedure) | during procedures | 
| Number of participitants with treatment-related adverse events | rate of hypocalcemia (ionized calcium <1,1 mmol/L, for each patient and for each procedure) | during procedures | 
| Number of participitants with treatment-related adverse events | rate of hypoalbuminemiafor for each patient and for each procedure) | during procedures | 
| Number of participitants with treatment-related adverse events | rate of thrombosis (confirmed by a CT scan or ultrasound, for each patient) | during procedures | 
| Number of participitants with treatment-related adverse events | rate of infections related catheter (for each patient) | during procedures | 
| Number of participitants with treatment-related adverse events | rate of allergics reactions (for each patient and for each procedure) | during procedures | 
| Number of participitants with treatment-related adverse events | rate of anemia (Hb < 7,0 g/dL, for each patient) | during procedures | 
| Number of participitants with treatment-related adverse events | rate of transfusion (for each patient) | during procedures | 
| Number of participitants with treatment-related adverse events | rate of haemostasis disorder (platelets < 100 <G/L ; TQ < 40 % ; fibrinogen < 1 G/L ; (for each patient and for each procedure) | during procedures | 
| Number of participitants with treatment-related adverse events | rate of death | during procedures | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, therapeutic exchange, neuropediatric, immunoadsorption