Condition category
Urological and Genital Diseases
Date applied
03/04/2014
Date assigned
03/04/2014
Last edited
08/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Central Manchester & Manchester Childrens University Hospital NHS Trust (UK)

Sponsor details

Department of Gastroenterology
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes