Outcome of BCF Access in Hemodialysis Patients (NCT01693263) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Outcome of BCF Access in Hemodialysis Patients
United States96 participantsStarted 2011-10
Plain-language summary
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.
Who can participate
Age range
21 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Patients will be excluded if they are less than 21 years of age
* 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.
* Those with a known history of anaphylaxis from contrast
* 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
Inclusion Criteria:
* No history of hemodialysis pr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.