Contact information
Type
Scientific
Primary contact
Dr David Makanjuola
ORCID ID
Contact details
Epsom and St. Helier NHS Trust
Renal Unit
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
+44 (0)20 8296 3685
david.makanjuola@epsom-sthelier.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0112146492
Study information
Scientific title
Acronym
Study hypothesis
Is the fibrin analysis system (FAS) endoluminal brush better than thrombolytics at restoring patency to blocked haemodialysis catheters?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Urological and Genital Diseases: Haemodialysis
Intervention
There will be two test groups of patients all experiencing a significant reduction in flow rate. This level will be defined as a flow rate that is less than 75% of the best flow rate achieved for that patient with the current catheter. Randomisation enrolment into Test Group 1 or 2 will be carried out by the patient enroller. Two random lists of 30 numbers have been generated. The first was assigned to brush intervention and second to urokinase intervention. The list was combined and ranked. The investigator will be provided with the blind ranked list, and assign each participant to the next sequential number. This code will be broken by an independent trialist, prior to intervention.
Added 20/07/09: the trial was stopped in 2002 due to recruitment issues.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Number of dialysis catheters restored to patency following the intervention.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2002
Overall trial end date
01/11/2004
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
Patients on haemodialysis at St Helier Hospital.
Intervention groups:
1. Catheterised haemodialysis patients with a flow rate less than 75% o best flow rate. Note that the same patient may be enrolled several times into the study if flow rate is reduced below 75% several times during the course of the study.
2. Patients new to dialysis or patients that have been on dialysis for a period of time.
3. All catheter types including temporary and permanent catheters.
4. All subjects must have a clinically defined optimal flow rate.
5. All subjects must have an x-ray prior to entry into the study - this would usually be done at the time a catheter is inserted to provide information on the site, tip position and length of catheter inserted.
6. No age restriction, both sexes, no other restrictions due to other illnesses or disorders.
Control Group:
The inclusion criteria for this group are as above, but patient must have flow rates >75% of the best flow rate acheived for that patient with the current catheter. This group will be used to establish baseline complication, time and cost data.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
Subject exclusion criteria from control and intervention groups:
1. Patients with kinked lines
2. Patients with occlusion due to fibrin sheath formation
Recruitment start date
01/11/2002
Recruitment end date
01/11/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Epsom and St. Helier NHS Trust
Carshalton
SM5 1AA
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Epsom and St Helier University Hospitals NHS Trust (UK), NHS R&D Support Funding
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