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

NCT04845516 | Completed

• 1 other identifier: RECHMPL21_0084
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Apheresis Related Complication

Keywords

Children; therapeutic exchange; neuropediatric; immunoadsorption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Incidence of therapeutic apheresis adverse events as assessed

  through study completion, an average of 2 years

• Incidence of adjuvant treatments

  through study completion, an average of 2 years

• Incidence of hospitalization in intensive care

  through study completion, an average of 2 years

• Description of the therapeutic apharesis modalities

  through study completion, an average of 2 years

• Description of the therapeutic apharesis modalities

  through study completion, an average of 2 years

Study Arms (2)

plasma exchange

All patients underwent plasma exchanges between 2014 and 2019 for a neuropediatric pathology

Other: Efficacy of apheresis

immunoadsorption

All patients who underwent immunoadsorptions between 2014 and 2019 for a neuropediatric pathology

Other: Efficacy of apheresis

Interventions

Efficacy of apheresis OTHER

Efficacy of apheresis

immunoadsorption; plasma exchange

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• \- Family or patient refusal to participate

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

Study Officials

• Maxime colmard, résident

  University Hospitals of Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: April 15, 2021
• Study Start: February 15, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

FR (1)