NCT05894317

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2025

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

2.1 years

First QC Date

May 30, 2023

Last Update Submit

February 21, 2025

Conditions

Vascular Access ComplicationApheresis Related Complication

Keywords

ApheresisDFPPANCA associated vasculitisGoodpasture syndromeArterio veinous fistulaArterio veinous graft

Outcome Measures

Primary Outcomes (1)

  • Vascular access Complication (catheter or AVF/AVG thrombosis/infection) rate in therapeutic apheresis among nephrological diseases

    Percent of patient with Vascular access Complication

    june 2020 june 2022

Secondary Outcomes (2)

  • Description of population enrolled

    june 2020 june 2022

  • Comparison of complications rate with literature datas

    june 2020 june 2022

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • apheresis treatment for other indications
  • centrifugation apheresis treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Hospital

Nancy, 54000, France

Location

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisAnti-Glomerular Basement Membrane Disease

Condition Hierarchy (Ancestors)

Systemic VasculitisVasculitisVascular DiseasesCardiovascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesGlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Luc Frimat, MD PhD

    CHRU NANCY DRCI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.CORBEL Alice Nephrology, MD

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 8, 2023

Study Start

June 1, 2020

Primary Completion

June 30, 2022

Study Completion

February 14, 2025

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)