Condition category
Urological and Genital Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
16/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes