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 |
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DOI | https://doi.org/10.1186/ISRCTN00873351 |
Secondary identifying numbers | N0112146492 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 16/12/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Urological and Genital Diseases
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
Contact information
Dr David Makanjuola
Scientific
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 |
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david.makanjuola@epsom-sthelier.nhs.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | Number of dialysis catheters restored to patency following the intervention. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/11/2002 |
Completion date | 01/11/2004 |
Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Epsom and St. Helier NHS Trust
Carshalton
SM5 1AA
United Kingdom
SM5 1AA
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
Epsom and St Helier University Hospitals NHS Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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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 |
IPD sharing plan |