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VACTANE: Vascular Access Complications for Therapeutic Apheresis in Nephrology

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05894317
Collaborator
(none)
60
Enrollment
1
Location
42
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to describe vascular access complications which are used for therapeutic apheresis in Nephrology.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim of this study is to describe vascular access complications which are used for therapeutic apheresis in Nephrology.

    Complications may include arterio-veinous fistula or graft (AVF or AVG) thrombosis with or without known stenosis; AVF or AVG or central veinous catheter (CVC) infections and CVC dysfunctions.

    We may enroll all patients receveing therapeutic apheresis for nephrologic indications in our unit:

    Nephrologics complications include :

    • acute or active antibody mediated rejection (ABMR),

    • Goodpasture disease,

    • ANCA vasculitis,

    • thrombotic angiopathy (TMA),

    • Focal segmental glomerulosclerosis (FSGS),

    • HLA or ABO desensitization for kidney transplantation.

    Data inclusion period is from June 2020 to June 2022.

    The aim of the study is to describe the proportion and type of complication in our population of patient receving therapeutic apheresis. We will study the risk factors that are associated with this complications.

    The second aim of the study is to describe the population of patient receving therapeutic apheresis in our unit and in our region.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Vascular Access Complications for Therapeutic Apheresis in Nephrology : a Retrospective Observational Study in North-East France.
    Actual Study Start Date :
    Jun 1, 2020
    Actual Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Nov 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Vascular access Complication rate in therapeutic apheresis [june 2020 june 2022]

      % of patient with Vascular access Complication

    Secondary Outcome Measures

    1. Description of population enrolled [june 2020 june 2022]

      Description of population treated by therapeutic apheresis in Northeast France

    2. Comparison of complications rate with literature datas [june 2020 june 2022]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patients in nephrology receiveing apheresis treatment by filtration or double filtration
    Exclusion Criteria:

    • apheresis treatment for other indications

    • centrifugation apheresis treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Central Hospital Nancy France 54000

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    • Principal Investigator: Luc Frimat, MD PhD, CHRU NANCY DRCI

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CORBEL Alice, CORBEL Alice MD, Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT05894317
    Other Study ID Numbers:
    • VACTANE
    First Posted:
    Jun 8, 2023
    Last Update Posted:
    Jun 8, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by CORBEL Alice, CORBEL Alice MD, Central Hospital, Nancy, France
    Apheresis
    DFPP
    ANCA associated vasculitis
    Goodpasture syndrome
    Arterio veinous fistula
    Arterio veinous graft

    Study Results

    No Results Posted as of Jun 8, 2023