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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05894317
Other study ID # VACTANE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date November 30, 2023

Study information

Verified date May 2023
Source Central Hospital, Nancy, France
Contact Asma Alla, MD
Phone +33 3 83153164
Email a.alla@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date November 30, 2023
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients in nephrology receiveing apheresis treatment by filtration or double filtration Exclusion Criteria: - apheresis treatment for other indications - centrifugation apheresis treatment

Study Design


Locations

Country Name City State
France Central Hospital Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vascular access Complication rate in therapeutic apheresis % of patient with Vascular access Complication june 2020 june 2022
Secondary Description of population enrolled Description of population treated by therapeutic apheresis in Northeast France june 2020 june 2022
Secondary Comparison of complications rate with literature datas june 2020 june 2022
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