- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02874391
Use of Arterio-venous Fistula as First Choice for Intravenous Drug Administration in Kidney Transplant Recipients (PerFAV)
January 19, 2017 updated by: University Hospital, Angers
Use of arteriovenous fistula for IV drug administration is controversial and often prohibited by nephrologists.
However, we have been using this method in our department for years now in order to keep the patients 'veins for other fistulas in the future.
The aim of this study is to evaluate our practice and maybe provide a justification for a larger multi-center study given the importance of this subject in patients with chronic renal failure.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
50
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
-
-
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Angers, France
- Recruiting
- CHU Angers
-
Contact:
- Christelle Roux
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Kidney transplant recipients
Description
Inclusion Criteria:
- Age > 18 years, functional AV fistula, new kidney transplant recipient
Exclusion Criteria:
- Prothetic AV fistula, Very recent AV fistula of less than 3 months
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
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
Control group
|
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AV fistula group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluate the risk of complications of AV fistula
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christelle Roux, University Hospital, Angers
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
September 1, 2016
Primary Completion (Anticipated)
September 1, 2019
Study Completion (Anticipated)
September 1, 2019
Study Registration Dates
First Submitted
August 17, 2016
First Submitted That Met QC Criteria
August 17, 2016
First Posted (Estimate)
August 22, 2016
Study Record Updates
Last Update Posted (Estimate)
January 20, 2017
Last Update Submitted That Met QC Criteria
January 19, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRIP-15-633
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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