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HemodialysisVyTesNCT01022359

Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters

A study testing TesioCath and LifeCath Twin in people with Hemodialysis, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to compare two available types of central venous haemodialysis catheters (lines) - CVCs, and will examine how easy they are to insert, complications, blood flow on dialysis over time, line loss, line clotting and infective events. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemodialysis
What is being tested?
TesioCath and LifeCath Twin
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2008to Sep 2011
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >=18 years old
  • No history of prior central venous catheter insertion
  • Medically fit for procedure (able to lie flat, no haemodynamic instability)
  • No active infection (recent positive blood cultures, clinical signs of infection, CRP>100)
  • Able to give informed consent
  • Expected to survive more than 12 months after catheter insertion

Who cannot join

  • As above

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

Other trials in United Kingdom

About this study

This study aims to compare two available types of central venous haemodialysis catheters (lines) - CVCs, and will examine how easy they are to insert, complications, blood flow on dialysis over time, line loss, line clotting and infective events. It will examine whether the LifeCath type of CVC can deliver high blood flow rates from first use after insertion and equivalent function and complication rate to the Tesio type of CVC that is in use in our centre already. Complications relating to dialysis access make up 30% of admissions for haemodialysis patients and so this is a study that could benefit patients and their care providers.

Read the detailed description

Complications relating to dialysis access make up to 30% of admissions in haemodialysis patients. Comparative studies of complications between dialysis lines can help physicians and patients choose the best CVC type. In addition determining a type of dialysis line that can deliver good blood flows from the outset can minimise length of hospital stay for access creation. This study aims to perform a head-to-head comparison of two very similar (twin catheter) dialysis lines and examine short and long-term function as well as complication rates at our centre.

Conditions
Hemodialysis
Being tested
TesioCath, LifeCath Twin
Keywords
haemodialysis, vascular access, central venous catheter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TesioCathDevice

    Also called BioFlex TesioCath (TM) - MedComp, Harleysville, PA, USA

    Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access

  • LifeCath TwinDevice

    Also called Vygon LifeCath Twin - Vygon(UK) Ltd, Cirencester, Gloucs, UK

    Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access

Study groups in NCT01022359
Study groupRoleWhat they receive
Tesio CatheterActive comparatorPatients randomised to receive the established catheter type in use at our centre [control]
Receives: Device: TesioCath
LifeCathActive comparatorPatients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)
Receives: Device: LifeCath Twin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Flow Rate at First Use After Insertion

    Measured: First haemodialysis session after insertion

Secondary outcomes (6)

  1. Achievement of Flow Rates>=450ml/Min at Dialysis Session

    Measured: flow rate measured at each session; session at 12 months reported

  2. Line Retention (Either/Both Lumens)

    Measured: 12 months

  3. Infective Episodes (Catheter & Non-catheter Related)

    Measured: 12 months

  4. Catheter Dysfunction Requiring Use of Thrombolytic Agents

    Measured: 12 months

  5. Complications at Catheter Insertion

    Measured: Day 1

  6. Recirculation Rates

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2009 (estimated)
  2. Study startOct 2008
  3. Primary completionJul 2010
  4. Study completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01022359
Sponsor's protocol ID
08/H0710/24
Acronym
VyTes
Status last verified
Mar 2021
First submitted
30 Nov 2009
Last updated
22 Apr 2021
Data monitoring committee
No

Publications

  • Duncan ND, Singh S, Cairns TD, Clark M, El-Tayar A, Griffith M, Hakim N, Hamady M, McLean AG, Papalois V, Palmer A, Taube D. Tesio-Caths provide effective and safe long-term vascular access. Nephrol Dial Transplant. 2004 Nov;19(11):2816-22. doi: 10.1093/ndt/gfh467. Epub 2004 Aug 31.

    PubMed 15340094

  • Perini S, LaBerge JM, Pearl JM, Santiestiban HL, Ives HE, Omachi RS, Graber M, Wilson MW, Marder SR, Don BR, Kerlan RK Jr, Gordon RL. Tesio catheter: radiologically guided placement, mechanical performance, and adequacy of delivered dialysis. Radiology. 2000 Apr;215(1):129-37. doi: 10.1148/radiology.215.1.r00mr43129.

    PubMed 10751478

  • Hassell DD 3rd, Vesely TM, Pilgram TK, Audrain JL. Initial performance of Tesio hemodialysis catheters. J Vasc Interv Radiol. 1999 May;10(5):553-8. doi: 10.1016/s1051-0443(99)70082-5.

    PubMed 10357479

  • Power A, Hill P, Singh SK, Ashby D, Taube D, Duncan N. Comparison of Tesio and LifeCath twin permanent hemodialysis catheters: the VyTes randomized trial. J Vasc Access. 2014 Mar-Apr;15(2):108-15. doi: 10.5301/jva.5000202. Epub 2014 Feb 5.

    PubMed 24500851

Questions about this trial

What is this clinical trial studying?

A study testing TesioCath and LifeCath Twin in people with Hemodialysis, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Flow Rate at First Use After Insertion (time frame: First haemodialysis session after insertion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01022359, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.

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