Comparison of the fibrin analysis system (FAS) endoluminal brush with currently accepted practice for restoring patency to blocked or partially blocked haemodialysis catheters.

ISRCTN	ISRCTN00873351
DOI	https://doi.org/10.1186/ISRCTN00873351
Protocol serial number	N0112146492
Sponsor	Department of Health
Funder	Epsom and St Helier University Hospitals NHS Trust (UK), NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr David Makanjuola
Scientific

Epsom and St. Helier NHS Trust
Renal Unit
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom

Phone	+44 (0)20 8296 3685
Email	david.makanjuola@epsom-sthelier.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Is the fibrin analysis system (FAS) endoluminal brush better than thrombolytics at restoring patency to blocked haemodialysis catheters?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Number of dialysis catheters restored to patency following the intervention.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/11/2004
Reason abandoned (if study stopped)	Participant recruitment issue

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
Key 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.
Key exclusion criteria	Subject exclusion criteria from control and intervention groups: 1. Patients with kinked lines 2. Patients with occlusion due to fibrin sheath formation
Date of first enrolment	01/11/2002
Date of final enrolment	01/11/2004

Epsom and St. Helier NHS Trust

Carshalton
SM5 1AA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan