Condition category
Surgery
Date applied
19/07/2010
Date assigned
27/04/2011
Last edited
25/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Laurence Solomon

ORCID ID

Contact details

Renal Unit
Royal Preston Hospital
Sharoe Green Lane
Preston
PR2 9HT
United Kingdom
laurie.solomon@lthtr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluating the need for thrombolytic therapy and incidence of bacteremia using taurolidine-citrate-heparin, taurololidine-citrate and heparin catheter locks in patients treated with haemodialysis: An open-label, observational study with retrospective comparator groups

Acronym

Study hypothesis

To determine whether addition of 500 units/ml of heparin to taurolidine-citrate catheter locks reduces the need for thrombolysis compared to taurolidine-citrate in haemodialysis patients using tunnelled intravascular catheters.

Ethics approval

This is an observational study based on routine clinical practice, which does not require ethics approval.

Study design

Open-label observational study with retrospective comparator groups

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Tunnelled intravascular catheters for haemodialysis

Intervention

Interdialytic locking with taurolidine-citrate-heparin (1.35% taurolidine, 4% citrate and 500 U/ml heparin) compared to taurolidine-citrate (1.35% taurolidine, 4% citrate) and heparin 5000U/ml.

Total duration of follow up is10 months.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

1. Time to first use thrombolysis for poor catheter flows
2. Time to first bacteremia

Secondary outcome measures

1. Incidence of gram-negative, gram-positive and staphylococcus aureus bacteraemia per 1000 catheter-days
2. Catheter survival after censoring for elective removal

Overall trial start date

01/03/2009

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

All adult haemodialysis patients requiring an internal jugular intravascular catheter for haemodialysis dialysing at single Haemodialysis Centre in NorthWest England.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

106

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/03/2009

Recruitment end date

31/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Renal Unit
Preston
PR2 9HT
United Kingdom

Sponsor information

Organisation

Lancashire Teaching Hospitals NHS trust (UK)

Sponsor details

Sharoe Green Lane
Preston
PR2 3LX
United Kingdom
laurie.solomon@lthtr.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Lancashire Teaching Hospitals NHS trust (UK)

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

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/21916999

Publication citations

  1. Results

    Solomon LR, Cheesbrough JS, Bhargava R, Mitsides N, Heap M, Green G, Diggle P, Observational study of need for thrombolytic therapy and incidence of bacteremia using taurolidine-citrate-heparin, taurolidine-citrate and heparin catheter locks in patients treated with hemodialysis., Semin Dial, 25, 2, 233-238, doi: 10.1111/j.1525-139X.2011.00951.x.

Additional files

Editorial Notes