Outcome of BCF Access in Hemodialysis Patients (BCF)
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|ClinicalTrials.gov Identifier: NCT01693263|
Recruitment Status : Active, not recruiting
First Posted : September 26, 2012
Last Update Posted : April 3, 2019
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.
|Condition or disease||Intervention/treatment|
|End Stage Renal Disease (ESRD) Brachiocephalic Fistula (BCF) Cephalic Arch Stenosis (CAS) Dialysis||Other: brachiocephalic fistula (BCF)|
|Study Type :||Observational|
|Actual Enrollment :||96 participants|
|Official Title:||A Clinical and Computational Study to Improve Brachiocephalic Fistula (BCF) Outcomes|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
brachiocephalic fistula placed
Subjects are being asked to participate in this study because they have end-stage renal disease and they are undergoing dialysis, and their doctor has recommended that they will have brachiocephalic fistula placed for their dialysis access.
Other: brachiocephalic fistula (BCF)
We will collect information from physical exams, blood tests, venogram, doppler, vein and artery tissue samples
As part of this study there is an additional sub-study. The researchers would like to collect more information about the vascular access from 50 subjects. For the purposes of this sub-study the following will take place: Intravenous Ultrasound (IVUS) and Hand Held Doppler
- Hemodynamic profile in subjects with BCF [ Time Frame: 5 years from start of study ]Observe a cohort of BCF subjects over time with protocol venograms and Dopplers and calculate WSS, along with other HDP, using CFD. This will enable a life table analysis to be derived to estimate the effect of WSS on time to CAS.
- Geometric change in cephalic arch in subjects with BCF [ Time Frame: 5 years from the start of the study ]Correlation of maximum change in average venous radius and change in arch angle with type of fistula, initial arch angle, and inlet pressure at the time of fistula formation.
Biospecimen Retention: Samples With DNA
Whole Blood Viscosity (WBV), Hematocrit, and ADMA: WBV will be measured by Brookfield Programmable DV-II+ cone plate viscometer. ADMA will be measured by ADMA ELISA kit. The samples will be collected every 6 months on all subjects and frozen to be run in aliquots of 50.
Cephalic Vein and Arterial Tissue Samples: During placement of BCF vein and arterial tissue are excised during anastomosis to create the fistula. After the tissue is removed from the vein and artery a small portion of each will be removed and collected for research from this discarded material. The cephalic vein and arterial samples will be collected and preserved in a tissue bank for later review by light and electron microscopy in a subsequent study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693263
|United States, Illinois|
|University of Chicago Medical Center|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Mary Hammes, MD||University of Chicago|