Vascular Access ComplicationVACTANENCT05894317
Vascular Access Complications for Therapeutic Apheresis in Nephrology
An observational study of Vascular Access Complication and Apheresis Related Complication, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The aim of this study is to describe vascular access complications which are used for therapeutic apheresis in Nephrology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Access Complication, Apheresis Related Complication
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 14 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients in nephrology receiveing apheresis treatment by filtration or double filtration with arterioveinous fistula or arterioveinous graft or central veinous catheter
Who may be able to join
- patients in nephrology receiveing apheresis treatment by filtration or double filtration
Who cannot join
- apheresis treatment for other indications
- centrifugation apheresis treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Apheresis, DFPP, ANCA associated vasculitis, Goodpasture syndrome, Arterio veinous fistula, Arterio veinous graft
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Anti-Glomerular Basement Membrane Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular access Complication (catheter or AVF/AVG thrombosis/infection) rate in therapeutic apheresis among nephrological diseases
Percent of patient with Vascular access Complication
Measured: june 2020 june 2022
Secondary outcomes (2)
Description of population enrolled
Description of population treated by therapeutic apheresis in Northeast France
Measured: june 2020 june 2022
Comparison of complications rate with literature datas
Measured: june 2020 june 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Jun 2020
- Primary completion30 Jun 2022
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CORBEL Alice, Central Hospital, Nancy, France
- Investigators
- Luc Frimat, MD PhD, Principal investigator, CHRU NANCY DRCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894317
- Sponsor's protocol ID
- 2022PI162
- Acronym
- VACTANE
- Status last verified
- Feb 2025
- First submitted
- 30 May 2023
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Access Complications for Therapeutic Apheresis in Nephrology : a Retrospective Observational Study in North-East France.
- ClinicalTrials.gov ID
- NCT05894317
- Acronym / sponsor ID
- VACTANE / 2022PI162
- Keywords
- Apheresis, DFPP, ANCA associated vasculitis, Goodpasture syndrome, Arterio veinous fistula, Arterio veinous graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to describe vascular access complications which are used for therapeutic apheresis in Nephrology.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients in nephrology receiveing apheresis treatment by filtration or double filtration with arterioveinous fistula or arterioveinous graft or central veinous catheter
Key inclusion criteria (1 listed)
- patients in nephrology receiveing apheresis treatment by filtration or double filtration
Key exclusion criteria (2 listed)
- apheresis treatment for other indications
- centrifugation apheresis treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Description of population enrolled
Time frame: june 2020 june 2022
Comparison of complications rate with literature datas
Time frame: june 2020 june 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Vascular Access Complication
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Not yet recruiting
Impact of a Long Peripheral Venous Catheter Protocol in Pediatric and Neonatal Care
Vascular Access Devices, Vascular Access
RecruitingObservational study
Mobilisation After Endovascular Stroke Treatment
Stroke, Acute Ischemic Stroke
RecruitingPhase 2
The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas
Amyloidosis, Basal Cell Carcinoma
Recruiting
ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
Type 1 Diabetes, Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Frimat, MD PhD principal investigator
CHRU NANCY DRCI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Access Complication and Apheresis Related Complication, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular access Complication (catheter or AVF/AVG thrombosis/infection) rate in therapeutic apheresis among nephrological diseases (time frame: june 2020 june 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.