Plain English Summary
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?
Anyone in need of upper limb AVF for haemodialysis can participate.
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?
Benefits: Patients will receive two additional scans and are closely monitored.
Risks: 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?
The study started in October 2011 and will close in June 2015.
Who is funding the study?
Bioconnect Systems Inc. (USA).
Who is the main contact?
Miss Carla Barrett
T: 0161 276 5196
F: 0161 701 7404
E: carla.barrett@cmft.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Miss Carla Barrett
ORCID ID
Contact details
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Carla.Barrett@cmft.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12048
Study information
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
Acronym
MANVAS
Study hypothesis
To understand the natural history of AVF maturation and identify factors influencing outcomes.
Ethics approval
NRES Committee North West Preston, 17/02/2011, ref. 11/H1016/3
Study design
Randomised; Interventional; Design type: Not specified, Screening
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please contact carla.barrett@cmft.nhs.uk to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
20/10/2011
Overall trial end date
30/06/2015
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 250; UK Sample Size: 250
Participant exclusion criteria
Inability to give consent and comply with the study follow-up schedule.
Recruitment start date
20/10/2011
Recruitment end date
30/06/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom
Funders
Funder type
Industry
Funder name
Bioconnect Systems Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary