Vascular Access Complications for Therapeutic Apheresis in Nephrology (VACTANE)

February 21, 2025 updated by: CORBEL Alice, Central Hospital, Nancy, France

Vascular Access Complications for Therapeutic Apheresis in Nephrology : a Retrospective Observational Study in North-East France.

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

Study Overview

Status

Completed

Conditions

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.

The investigators may enroll all patients receveing therapeutic apheresis for nephrologic indications in North East France.

Nephrologics indications include :

  • acute or active antibody mediated rejection (ABMR),
  • Goodpasture disease,
  • ANCA vasculitis,
  • thrombotic microangiopathy (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 the population of patient receving therapeutic apheresis for nephrologic disease in the North East France. Te investigators 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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

patients in nephrology receiveing apheresis treatment by filtration or double filtration with arterioveinous fistula or arterioveinous graft or central veinous catheter

Description

Inclusion Criteria:

  • patients in nephrology receiveing apheresis treatment by filtration or double filtration

Exclusion Criteria:

  • apheresis treatment for other indications
  • centrifugation apheresis treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular access Complication (catheter or AVF/AVG thrombosis/infection) rate in therapeutic apheresis among nephrological diseases
Time Frame: june 2020 june 2022
Percent of patient with Vascular access Complication
june 2020 june 2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of population enrolled
Time Frame: june 2020 june 2022
Description of population treated by therapeutic apheresis in Northeast France
june 2020 june 2022
Comparison of complications rate with literature datas
Time Frame: june 2020 june 2022
june 2020 june 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

February 14, 2025

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022PI162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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