Skip to main content
OpenTrials
Completed

NCT Number: NCT04845516

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34295, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Efficacy of apheresis

Other

Efficacy of apheresis

Primary outcomes

  1. global neurological efficacy of therapeutic apheresis as assessed

    Time frame: 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 outcomes

  1. Incidence of therapeutic apheresis adverse events as assessed

    Time frame: 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).

  2. Incidence of adjuvant treatments

    Time frame: through study completion, an average of 2 years

    Incidence of adjuvant treatments (corticosteroid therapy, immunoglobulins, immunosuppressants),

  3. Incidence of hospitalization in intensive care

    Time frame: through study completion, an average of 2 years

    Incidence of hospitalization in intensive care, intubation rate

  4. Description of the therapeutic apharesis modalities

    Time frame: through study completion, an average of 2 years

    number of procedures

  5. Description of the therapeutic apharesis modalities

    Time frame: through study completion, an average of 2 years

    exchanged volume (in plasma volume percentage) for each procedure

  6. Description of the therapeutic apharesis modalities

    Time frame: through study completion, an average of 2 years

    type of separation et number of participants with ttt-related advesre events

  7. Description of the therapeutic apharesis modalities

    Time frame: through study completion, an average of 2 years

    type of replacement solution (isotonic saline, albumin, fresh frozen plasma)

  8. Number of participitants with treatment-related adverse events

    Time frame: during procedures

    rate of arterial hypotension (< age standards and and requiring isotonic saline bolus, for each patient and for procedure)

  9. Number of participitants with treatment-related adverse events

    Time frame: during procedures

    rate of hypocalcemia (ionized calcium <1,1 mmol/L, for each patient and for each procedure)

  10. Number of participitants with treatment-related adverse events

    Time frame: during procedures

    rate of hypoalbuminemiafor for each patient and for each procedure)

  11. Number of participitants with treatment-related adverse events

    Time frame: during procedures

    rate of thrombosis (confirmed by a CT scan or ultrasound, for each patient)

  12. Number of participitants with treatment-related adverse events

    Time frame: during procedures

    rate of infections related catheter (for each patient)

  13. Number of participitants with treatment-related adverse events

    Time frame: during procedures

    rate of allergics reactions (for each patient and for each procedure)

  14. Number of participitants with treatment-related adverse events

    Time frame: during procedures

    rate of anemia (Hb < 7,0 g/dL, for each patient)

  15. Number of participitants with treatment-related adverse events

    Time frame: during procedures

    rate of transfusion (for each patient)

  16. Number of participitants with treatment-related adverse events

    Time frame: during procedures

    rate of haemostasis disorder (platelets < 100 <G/L ; TQ < 40 % ; fibrinogen < 1 G/L ; (for each patient and for each procedure)

  17. Number of participitants with treatment-related adverse events

    Time frame: during procedures

    rate of death

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 15, 2021
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.