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

Completed

• Conditions: Apheresis Related Complication
• Interventions: Other: Efficacy of apheresis

• Registration Number: NCT04845516
• Lead Sponsor: University Hospital, Montpellier

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

Study Timeline

• Study Start: 2021-02-15
• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-15
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
plasma exchange	Efficacy of apheresis	All patients underwent plasma exchanges between 2014 and 2019 for a neuropediatric pathology
immunoadsorption	Efficacy of apheresis	All patients who underwent immunoadsorptions between 2014 and 2019 for a neuropediatric pathology

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of therapeutic apheresis adverse events as assessed	through study completion, an average of 2 years	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).
Description of the therapeutic apharesis modalities	through study completion, an average of 2 years	type of replacement solution (isotonic saline, albumin, fresh frozen plasma)
Number of participitants with treatment-related adverse events	during procedures	rate of death
Incidence of adjuvant treatments	through study completion, an average of 2 years	Incidence of adjuvant treatments (corticosteroid therapy, immunoglobulins, immunosuppressants),
Incidence of hospitalization in intensive care	through study completion, an average of 2 years	Incidence of hospitalization in intensive care, intubation rate

Trial Locations

Locations (1)

Uh Montpellier; 🇫🇷 Montpellier, France