NCT01693263Active, not recruiting
Outcome of BCF Access in Hemodialysis Patients
A Clinical and Computational Study to Improve Brachiocephalic Fistula (BCF) Outcomes
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
Dialysis access, which is the connection that allows blood to flow in and out of the body during dialysis sessions, is important to remove wastes and excess fluid for patients with end stage renal disease (ESRD). One method used to access the vein and artery for dialysis is called a brachiocephalic fistula. Patients are being asked to participate in this study because they have endstage renal disease, and their doctor has recommended that they will have brachiocephalic fistula placed for their dialysis access. A common problem seen in patients with a brachiocephalic fistula (BCF) is cephalic arch stenosis (CAS). CAS is a narrowing in the central vein (located in the upper chest). CAS causes problems with the opening of the veins and arteries needed for dialysis. Once someone suffers CAS they may need several radiology procedures as well as surgery to help correct the problem. The BCF may fail once CAS develops. The purpose of the research study is to gather information about the BCF and what is happening inside the vein. The researchers hope to find out what may be the cause of CAS.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 96 (actual)
- First submitted
- 8 Aug 2012
- Start date
- 1 Oct 2011
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- University of Chicago
- Diseases
- Chronic kidney disease
- NCT number
- NCT01693263
What you commit to
- Study type: Observational
- Participants enrolled: 96
- From 1 Oct 2011 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who are found to be ineligible to have a surgical placement of a BCF as determined by the surgeon
- Additional Criteria for the sub-study
- History of hemodialysis prior to BCF access placement
Other illness
- Those with a known history of anaphylaxis from contrast
Lab values
- Pregnant females will be excluded. A careful history will be taken and women who are pregnant or have a clinical indication will have a serum pregnancy test with a positive result will be excluded.
Age
- Patients will be excluded if they are less than 21 years of age
Who the study is looking for
- Subjects enrolled in the study will include patients with irreversible chronic renal failure; either those receiving chronic hemodialysis or anticipation that hemodialysis will be required.
- Subjects for consideration in the study will be referred from the out-patient nephrology clinic at the University of Chicago or a dialysis unit affiliated with DaVita Dialysis for a primary AVF. The patient will be referred for AVF placement and evaluated at the University of Chicago by a transplant or vascular surgeon. If it is determined that the patient is a candidate for fistula placement, the surgeon will decide based on physical exam, the best location for the access. If the optimal location is a proposed BCF, a research coordinator will be notified and the patient will be enrolled by written consent approved by the IRB from the University of Chicago.
- Subjects who can provide consent or consent of a surrogate through proxy
- No history of hemodialysis prior to BCF access placement
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.