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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04845516
Enrollment
200
Registered
2021-04-15
Start date
2021-02-15
Completion date
2021-12-31
Last updated
2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apheresis Related Complication

Keywords

Children, therapeutic exchange, neuropediatric, immunoadsorption

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

Interventions

OTHEREfficacy of apheresis

Efficacy of apheresis

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
global neurological efficacy of therapeutic apheresis as assessedthrough study completion, an average of 2 yearslobal neurological efficacy of therapeutic apheresis as assessed by modified rankin score Modifed Rankin score, ranging from 0 (no symptoms) to 6 (death)

Secondary

MeasureTime frameDescription
Incidence of therapeutic apheresis adverse events as assessedthrough study completion, an average of 2 yearstIncidence 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).
Incidence of adjuvant treatmentsthrough study completion, an average of 2 yearsIncidence of adjuvant treatments (corticosteroid therapy, immunoglobulins, immunosuppressants),
Incidence of hospitalization in intensive carethrough study completion, an average of 2 yearsIncidence of hospitalization in intensive care, intubation rate
Description of the therapeutic apharesis modalitiesthrough study completion, an average of 2 yearsnumber of procedures
Number of participitants with treatment-related adverse eventsduring proceduresrate of arterial hypotension (\< age standards and and requiring isotonic saline bolus, for each patient and for procedure)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026