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DFPPSURV: Evaluation of the Efficacy and Tolerance of Plasmapheresis by Double Cascade Filtration in a University Centre

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Completed
CT.gov ID
NCT04261205
Collaborator
(none)
70
Enrollment
1
Location
27.3
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study is being carried out to evaluate the biological, technical and clinical/biological efficacy of this technique, the practice of which is standardized in the department, in order to evaluate our practices and to improve them if necessary. As part of this study, the investigators will ask all patients scheduled for this procedure to participate in this observational prospective study without changing usual practices.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The objective of the study is to conduct a prospective evaluation of the practice of apheresis by Double Filtration System Cascade system in a university centre in current practice with evaluation of the technical and biological effectiveness as the main objective and clinical and biological tolerance as the secondary objective for all consecutive sessions performed in a university centre over a period of 1 year.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    70 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of the Efficacy and Tolerance of Plasmapheresis by Double Cascade Filtration in a University Centre
    Actual Study Start Date :
    Aug 4, 2018
    Actual Primary Completion Date :
    Oct 17, 2020
    Actual Study Completion Date :
    Nov 13, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Apheresis by DFPP and biological efficiency [over a period of one year]

      quantification of the purification carried out (volume)

    Secondary Outcome Measures

    1. Clinical side effects [within 1 hour of all session]

      catheter dysfunction

    2. Biological side effects [within 1 hour of all session]

      Bleeding rate

    3. variation of Hb, platelet and albumin before and after session [within 1 hour of all session]

      % of Hb, platelet and albumin

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 99 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    Over 18 years of age I indication for plasmapheresis and hospitalized at Chu de Nimes.

    Exclusion Criteria:

    Under guardianship or curatorship Refusal to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Nîmes, Hôpital Universitaire Caremeau Nîmes France 30029

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Nīmes

    Investigators

    • Principal Investigator: Olivier Moranne, MD, PhD, CHU Nîmes

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Nīmes
    ClinicalTrials.gov Identifier:
    NCT04261205
    Other Study ID Numbers:
    • Local/2017/0M-01
    First Posted:
    Feb 7, 2020
    Last Update Posted:
    Nov 16, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire de Nīmes
    Chronic hemodialysis
    Additional relevant MeSH terms:
    Renal Insufficiency

    Study Results

    No Results Posted as of Nov 16, 2020