A retrospective review of the outcomes of patients receiving a bovine artery graft for dialysis access
| ISRCTN | ISRCTN28160715 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28160715 |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | STUDY00001258 |
- Submission date
- 10/05/2021
- Registration date
- 16/06/2021
- Last edited
- 16/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Normally, the kidneys filter the blood, removing harmful waste products and excess fluid and turning these into urine to be passed out of the body. Dialysis is a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly. Dialysis often involves diverting blood out of the body to a machine that acts similarly to a kidney to filter the blood and then is returned to the body. In order to remove and return the blood from the body on multiple occasions for dialysis, a point of access will be created surgically. There are a number of methods that may be used including an arteriovenous graft which is a looped tube that connects an artery to a vein. This tube may be made of plastic such as polytetrafluoroethylene (PTFE) or biological material such as bovine carotid artery.
This study will compare whether the grafted tube remains open to the flow of blood 12 months after surgery in patients who received a bovine carotid artery graft.
Who can participate?
Adult patients who received surgical placement of a bovine carotid artery graft between 2017-2018
What does the study involve?
This study involves a retrospective review of all patients undergoing surgical placement of a bovine carotid artery graft for dialysis access between 2017-2018 at Louisiana State University Health Sciences Center.
Data on the extent to which the graft remains open to allow blood flow (patency) will be collected from patient records for the whole cohort and results determined based on gender, BMI, and indication for use. The outcomes of bovine carotid artery grafts will be compared to polytetrafluoroethylene (PTFE) grafts performed at the same institution between 2013 and 2016.
What are the possible benefits and risks of participating?
There is no human risk involved as this is retrospective study.
Where is the study run from?
Louisiana State University Health Sciences Center (USA)
When is the study starting and how long is it expected to run for?
From September 2019 to September 2021
Who is funding the study?
Who is the main contact?
Dr Chiranjiv Virk, cvirk@lsuhsc.edu
Contact information
Scientific
9011 Vue Fleur Lane
Shreveport
71106
United States of America
 ORCID ID |
0000-0002-7845-215X |
|---|---|
| Phone | +1 9178625505 |
| virkchiranjiv@hotmail.com |
Study information
| Study design | Retrospective review |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A retrospective review of bovine artery graft patency: a single site study |
| Study objectives | To look at the outcome of the bovine carotid artery grafts for dialysis at a single institution, and compare these results for polytetrafluoroethylene (PTFE) grafts |
| Ethics approval(s) | Approved 31/10/2019, Louisiana State University Health Sciences Center - Shreveport Institutional Review Board (LSUHSC-S IRB) (2nd Floor, Admin Building, 1501 Kings Hwy, Shreveport, LA 71103; +1 318-813-1359; no email address available), ref: STUDY00001258 |
| Health condition(s) or problem(s) studied | Bovine artery graft, arteriovenous graft, end-stage renal disease, hemodialysis, dialysis access |
| Intervention | The retrospective review will involve the review of participant charts between 01/01/2017 and 15/08/2019 to assess patency following bovine artery graft procedure. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Primary and primary-assisted patency rates at 12 months measured from patient charts at a single timepoint |
| Secondary outcome measures | Secondary patency at 12 months measured from patient charts at a single timepoint |
| Overall study start date | 26/09/2019 |
| Completion date | 10/09/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 74 |
| Total final enrolment | 74 |
| Key inclusion criteria | Bovine artery graft placed between 01/01/2017 and 15/08/2019 |
| Key exclusion criteria | 1. Unable to consent 2. Aged <18 years 3. Pregnancy 4. Prisoners |
| Date of first enrolment | 01/01/2017 |
| Date of final enrolment | 15/08/2019 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Shreveport
71130
United States of America
Sponsor information
Hospital/treatment centre
1501 K Hway
Shreveport
71130
United States of America
| Phone | +1 9178625505 |
|---|---|
| CVIRK@LSUHSC.EDU | |
| Website | https://www.lsuhs.edu/research/irb |
"ROR" |
https://ror.org/01qv8fp92 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 08/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high impact peer-reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
16/06/2021: Trial’s existence confirmed by the Louisiana State University Health Sciences Center - Shreveport Institutional Review Board (LSUHSC-S IRB).
