Uh Montpellier
Montpellier, 34295, France
NCT Number: NCT04845516
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.
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Notify MeUp to 18 year
All sexes
Observational
Montpellier, 34295, France
Multicenter medical data collection :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Efficacy of apheresis
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)
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).
Time frame: through study completion, an average of 2 years
Incidence of adjuvant treatments (corticosteroid therapy, immunoglobulins, immunosuppressants),
Time frame: through study completion, an average of 2 years
Incidence of hospitalization in intensive care, intubation rate
Time frame: through study completion, an average of 2 years
number of procedures
Time frame: through study completion, an average of 2 years
exchanged volume (in plasma volume percentage) for each procedure
Time frame: through study completion, an average of 2 years
type of separation et number of participants with ttt-related advesre events
Time frame: through study completion, an average of 2 years
type of replacement solution (isotonic saline, albumin, fresh frozen plasma)
Time frame: during procedures
rate of arterial hypotension (< age standards and and requiring isotonic saline bolus, for each patient and for procedure)
Time frame: during procedures
rate of hypocalcemia (ionized calcium <1,1 mmol/L, for each patient and for each procedure)
Time frame: during procedures
rate of hypoalbuminemiafor for each patient and for each procedure)
Time frame: during procedures
rate of thrombosis (confirmed by a CT scan or ultrasound, for each patient)
Time frame: during procedures
rate of infections related catheter (for each patient)
Time frame: during procedures
rate of allergics reactions (for each patient and for each procedure)
Time frame: during procedures
rate of anemia (Hb < 7,0 g/dL, for each patient)
Time frame: during procedures
rate of transfusion (for each patient)
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)
Time frame: during procedures
rate of death
University Hospital, Montpellier
Other
Efficacy and Tolerance of Therapeutic Apheresis in Paediatric Neurology: a Retrospective French Multicenter Study
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