Apheresis Related ComplicationNCT04845516
Efficacy and Tolerance of Therapeutic Apheresis in Paediatric Neurology: a French Multicenter Study
An observational study of Apheresis Related Complication, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Apheresis Related Complication
- What is being tested?
- Efficacy of apheresis
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- Family or patient refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerance of Therapeutic Apheresis in Paediatric Neurology: a Retrospective 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.
Read the 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
- Conditions
- Apheresis Related Complication
- Being tested
- Efficacy of apheresis
- Keywords
- Children, therapeutic exchange, neuropediatric, immunoadsorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy of apheresisOther
Efficacy of apheresis
| Study group | Role | What they receive |
|---|---|---|
| plasma exchange | All patients underwent plasma exchanges between 2014 and 2019 for a neuropediatric pathology Receives: Other: Efficacy of apheresis | |
| immunoadsorption | All patients who underwent immunoadsorptions between 2014 and 2019 for a neuropediatric pathology Receives: Other: Efficacy of apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 2 years
Secondary outcomes (17)
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).
Measured: through study completion, an average of 2 years
Incidence of adjuvant treatments
Incidence of adjuvant treatments (corticosteroid therapy, immunoglobulins, immunosuppressants),
Measured: through study completion, an average of 2 years
Incidence of hospitalization in intensive care
Incidence of hospitalization in intensive care, intubation rate
Measured: through study completion, an average of 2 years
Description of the therapeutic apharesis modalities
number of procedures
Measured: through study completion, an average of 2 years
Description of the therapeutic apharesis modalities
exchanged volume (in plasma volume percentage) for each procedure
Measured: through study completion, an average of 2 years
Description of the therapeutic apharesis modalities
type of separation et number of participants with ttt-related advesre events
Measured: through study completion, an average of 2 years
Description of the therapeutic apharesis modalities
type of replacement solution (isotonic saline, albumin, fresh frozen plasma)
Measured: through study completion, an average of 2 years
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)
Measured: during procedures
Number of participitants with treatment-related adverse events
rate of hypocalcemia (ionized calcium <1,1 mmol/L, for each patient and for each procedure)
Measured: during procedures
Number of participitants with treatment-related adverse events
rate of hypoalbuminemiafor for each patient and for each procedure)
Measured: during procedures
Number of participitants with treatment-related adverse events
rate of thrombosis (confirmed by a CT scan or ultrasound, for each patient)
Measured: during procedures
Number of participitants with treatment-related adverse events
rate of infections related catheter (for each patient)
Measured: during procedures
Number of participitants with treatment-related adverse events
rate of allergics reactions (for each patient and for each procedure)
Measured: during procedures
Number of participitants with treatment-related adverse events
rate of anemia (Hb < 7,0 g/dL, for each patient)
Measured: during procedures
Number of participitants with treatment-related adverse events
rate of transfusion (for each patient)
Measured: during procedures
Number of participitants with treatment-related adverse events
rate of haemostasis disorder (platelets < 100 <G/L ; TQ < 40 % ; fibrinogen < 1 G/L ; (for each patient and for each procedure)
Measured: during procedures
Number of participitants with treatment-related adverse events
rate of death
Measured: during procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start15 Feb 2021
- Primary completion1 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apheresis Related ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime colmard, résident, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845516
- Sponsor's protocol ID
- RECHMPL21_0084
- Status last verified
- Apr 2022
- First submitted
- 16 Feb 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance of Therapeutic Apheresis in Paediatric Neurology: a Retrospective French Multicenter Study
- ClinicalTrials.gov ID
- NCT04845516
- Acronym / sponsor ID
- RECHMPL21_0084
- Conditions
- Apheresis Related Complication
- Keywords
- Children, therapeutic exchange, neuropediatric, immunoadsorption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plasma exchange | – | Other: Efficacy of apheresisAll patients underwent plasma exchanges between 2014 and 2019 for a neuropediatric pathology |
| immunoadsorption | – | Other: Efficacy of apheresisAll patients who underwent immunoadsorptions between 2014 and 2019 for a neuropediatric pathology |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Family or patient refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efficacy of apheresisEfficacy of apheresis | Other | immunoadsorption, plasma exchange |
Primary outcome
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)
17 secondary outcomes
Incidence of therapeutic apheresis adverse events as assessed
Time frame: through study completion, an average of 2 years
Incidence of adjuvant treatments
Time frame: through study completion, an average of 2 years
Incidence of hospitalization in intensive care
Time frame: through study completion, an average of 2 years
Description of the therapeutic apharesis modalities
Time frame: through study completion, an average of 2 years
Description of the therapeutic apharesis modalities
Time frame: through study completion, an average of 2 years
Description of the therapeutic apharesis modalities
Time frame: through study completion, an average of 2 years
Description of the therapeutic apharesis modalities
Time frame: through study completion, an average of 2 years
Number of participitants with treatment-related adverse events
Time frame: during procedures
Number of participitants with treatment-related adverse events
Time frame: during procedures
Number of participitants with treatment-related adverse events
Time frame: during procedures
Number of participitants with treatment-related adverse events
Time frame: during procedures
Number of participitants with treatment-related adverse events
Time frame: during procedures
Number of participitants with treatment-related adverse events
Time frame: during procedures
Number of participitants with treatment-related adverse events
Time frame: during procedures
Number of participitants with treatment-related adverse events
Time frame: during procedures
Number of participitants with treatment-related adverse events
Time frame: during procedures
Number of participitants with treatment-related adverse events
Time frame: during procedures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime colmard, résident principal investigator
University Hospitals of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apheresis Related Complication, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
global neurological efficacy of therapeutic apheresis as assessed (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.