Clinical trial NCT04845516: Efficacy and Tolerance of Therapeutic Apheresis in Paediatric Neurology: a French Multicenter Study
Official title: Efficacy and Tolerance of Therapeutic Apheresis in Paediatric Neurology: a Retrospective French Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apheresis Related Complication
Keywords: Children
therapeutic exchange
neuropediatric
immunoadsorption
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 18, Supported in a participating CHU between 2014 and 2019 and Having benefited from therapeutic apheresis (plasma exchanges and immunoadsorption) in a neuropediatric indication

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

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

Primary outcomes:
measure: global neurological efficacy of therapeutic apheresis as assessed
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Incidence of therapeutic apheresis adverse events as assessed
timeFrame: through study completion, an average of 2 years
measure: Incidence of adjuvant treatments
timeFrame: through study completion, an average of 2 years
measure: Incidence of hospitalization in intensive care
timeFrame: through study completion, an average of 2 years
measure: Description of the therapeutic apharesis modalities
timeFrame: through study completion, an average of 2 years
measure: Description of the therapeutic apharesis modalities
timeFrame: through study completion, an average of 2 years
measure: Description of the therapeutic apharesis modalities
timeFrame: through study completion, an average of 2 years
measure: Description of the therapeutic apharesis modalities
timeFrame: through study completion, an average of 2 years
measure: Number of participitants with treatment-related adverse events
timeFrame: during procedures
measure: Number of participitants with treatment-related adverse events
timeFrame: during procedures
measure: Number of participitants with treatment-related adverse events
timeFrame: during procedures
measure: Number of participitants with treatment-related adverse events
timeFrame: during procedures
measure: Number of participitants with treatment-related adverse events
timeFrame: during procedures
measure: Number of participitants with treatment-related adverse events
timeFrame: during procedures
measure: Number of participitants with treatment-related adverse events
timeFrame: during procedures
measure: Number of participitants with treatment-related adverse events
timeFrame: during procedures
measure: Number of participitants with treatment-related adverse events
timeFrame: during procedures
measure: Number of participitants with treatment-related adverse events
timeFrame: during procedures
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Maxime colmard, résident
role: PRINCIPAL_INVESTIGATOR
References: