Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters (VyTes)

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis
• Intervention / Treatment: Device: TesioCath; Device: LifeCath Twin

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W12 0HS
    • Imperial College Healthcare NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• As above

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tesio Catheter; Patients randomised to receive the established catheter type in use at our centre [control]	Device: TesioCath; Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access; Other Names: BioFlex TesioCath (TM) - MedComp, Harleysville, PA, USA
Active Comparator: LifeCath; Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)	Device: LifeCath Twin; Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access; Other Names: Vygon LifeCath Twin - Vygon(UK) Ltd, Cirencester, Gloucs, UK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood Flow Rate at First Use After Insertion	First haemodialysis session after insertion

Secondary Outcome Measures

Outcome Measure	Time Frame
Achievement of Flow Rates>=450ml/Min at Dialysis Session	flow rate measured at each session; session at 12 months reported
Line Retention (Either/Both Lumens)	12 months
Infective Episodes (Catheter & Non-catheter Related)	12 months
Catheter Dysfunction Requiring Use of Thrombolytic Agents	12 months
Complications at Catheter Insertion	Day 1
Recirculation Rates	12 months

Collaborators and Investigators

• Sponsor: Imperial College Healthcare NHS Trust
• Investigators: Principal Investigator: Neill Duncan, MBBS MRCP, Imperial College Healthcare NHS Trust; Study Director: Albert Power, MBBChir MRCP, Imperial College Healthcare NHS Trust

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: November 30, 2009
• First Submitted That Met QC Criteria: November 30, 2009
• First Posted (Estimate): December 1, 2009

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: haemodialysis; central venous catheter; vascular access
• Other Study ID Numbers: 08/H0710/24