Manchester vascular access study
| ISRCTN | ISRCTN57422410 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57422410 |
| Secondary identifying numbers | 12048 |
- Submission date
- 03/04/2014
- Registration date
- 03/04/2014
- Last edited
- 24/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Haemodialysis (HD) is a life-saving and life-sustaining treatment. Effective HD requires a reliable, long-term and safe vascular access (approach into the blood stream). Native AV fistulae (AVFs) are the preferred vascular access for their low complication rates and longevity. However, AVFs have high early failure rates, but once matured they have a relatively longer operational life and a lower complication rate, especially from infections, when compared to prosthetic grafts (AVGs) and dialysis catheters. This study aims to understand the natural history of AVF maturation and identify factors influencing outcomes.
Who can participate?
Patients in need of upper limb AVF for haemodialysis
What does the study involve?
The patient attends three extra scans. Blood samples are taken and the patient is followed up over a monthly basis for a year. They may have two additional visits to the hospital.
What are the possible benefits and risks of participating?
Participants receive two additional scans and are closely monitored. Participants may need to have extra needles inserted for research blood tests, although every effort will be made to take them at the scheduled blood tests, thus further reducing the small risks associated with taking blood from the veins.
Where is the study run from?
Central Manchester University Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
October 2011 to March 2022
Who is funding the study?
Bioconnect Systems Inc. (USA)
Who is the main contact?
Miss Carla Barrett
carla.barrett@cmft.nhs.uk
Contact information
Scientific
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
| Carla.Barrett@cmft.nhs.uk |
Study information
| Study design | Randomised; Interventional; Design type: Not specified, Screening |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please contact carla.barrett@cmft.nhs.uk to request a patient information sheet |
| Scientific title | Understanding haemodialysis vascular access maturation: a prospective observational study to understand the natural history and biology of AV access maturation and identify risk factors for AVF failure |
| Study acronym | MANVAS |
| Study objectives | To understand the natural history of AVF maturation and identify factors influencing outcomes. |
| Ethics approval(s) | NRES Committee North West Preston, 17/02/2011, ref. 11/H1016/3 |
| Health condition(s) or problem(s) studied | Topic: Renal disorders; Subtopic: Renal disorders; Disease: All Renal disorders |
| Intervention | Extra bloods at baseline: Patients will have an extra blood test at this point for haematological/biochemical parameters and DNA/stem cell sampling and analysis. Extra blood tests will be optional and will not be mandatory for all participating centres. Perioperatively - blood tests, patients will undergo further blood tests peri-operatively and these will be linked to their peri-operative clinically indicated blood tests; blood tests will be optional and are not mandatory for study inclusion. US scan - follow-up, Doppler ultrasound scan will be used to assess maturation. It is anticipated that most patients will have two extra visits with tests during their visits (routine postoperative visit and scan at 6 weeks is standard clinical practice). For the minority of patients who have not used their fistula by 6 months, we will perform the final study evaluation with US at 6 months. |
| Intervention type | Other |
| Primary outcome measure | Successful (unassisted) maturation defined as either A or B A: Use of the AVF with two needles |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 20/10/2011 |
| Completion date | 01/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 250; UK Sample Size: 250 |
| Key inclusion criteria | 1. The participant is in need of AV dialysis access for haemodialysis. 2. Participant is available and can return for follow-up visits Target Gender: Male & Female ; Lower Age Limit 18 years |
| Key exclusion criteria | Inability to give consent and comply with the study follow-up schedule |
| Date of first enrolment | 20/10/2011 |
| Date of final enrolment | 30/06/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
M13 9WL
United Kingdom
Sponsor information
Hospital/treatment centre
Department of Gastroenterology
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9PL
England
United Kingdom
"ROR" |
https://ror.org/00he80998 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration 2014 thesis in https://www.research.manchester.ac.uk/portal/files/54552626/FULL_TEXT.PDF (added 01/09/2020) |
| IPD sharing plan |
Editorial Notes
24/09/2020: The overall trial end date has been changed from 30/06/2015 to 01/03/2022 and the plain English summary has been updated accordingly.
01/09/2020: Added link to thesis.
10/08/2017: No publications found, verifying study status with principal investigator.
