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

Apheresis Related Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04845516
• Other study ID #: RECHMPL21_0084
• Status: Completed
• Start date: February 15, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Apheresis Related Complication

Intervention

Other:
• Efficacy of apheresis
Efficacy of apheresis

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of therapeutic apheresis adverse events as assessed	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).	through study completion, an average of 2 years
Secondary	Incidence of adjuvant treatments	Incidence of adjuvant treatments (corticosteroid therapy, immunoglobulins, immunosuppressants),	through study completion, an average of 2 years
Secondary	Incidence of hospitalization in intensive care	Incidence of hospitalization in intensive care, intubation rate	through study completion, an average of 2 years
Secondary	Description of the therapeutic apharesis modalities	number of procedures	through study completion, an average of 2 years
Secondary	Description of the therapeutic apharesis modalities	exchanged volume (in plasma volume percentage) for each procedure	through study completion, an average of 2 years
Secondary	Description of the therapeutic apharesis modalities	type of separation et number of participants with ttt-related advesre events	through study completion, an average of 2 years
Secondary	Description of the therapeutic apharesis modalities	type of replacement solution (isotonic saline, albumin, fresh frozen plasma)	through study completion, an average of 2 years
Secondary	Number of participitants with treatment-related adverse events	rate of arterial hypotension (< age standards and and requiring isotonic saline bolus, for each patient and for procedure)	during procedures
Secondary	Number of participitants with treatment-related adverse events	rate of hypocalcemia (ionized calcium <1,1 mmol/L, for each patient and for each procedure)	during procedures
Secondary	Number of participitants with treatment-related adverse events	rate of hypoalbuminemiafor for each patient and for each procedure)	during procedures
Secondary	Number of participitants with treatment-related adverse events	rate of thrombosis (confirmed by a CT scan or ultrasound, for each patient)	during procedures
Secondary	Number of participitants with treatment-related adverse events	rate of infections related catheter (for each patient)	during procedures
Secondary	Number of participitants with treatment-related adverse events	rate of allergics reactions (for each patient and for each procedure)	during procedures
Secondary	Number of participitants with treatment-related adverse events	rate of anemia (Hb < 7,0 g/dL, for each patient)	during procedures
Secondary	Number of participitants with treatment-related adverse events	rate of transfusion (for each patient)	during procedures
Secondary	Number of participitants with treatment-related adverse events	rate of haemostasis disorder (platelets < 100	during procedures
Secondary	Number of participitants with treatment-related adverse events	rate of death	during procedures