Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters
VyTes
1 other identifier
interventional
80
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 30, 2009
CompletedFirst Posted
Study publicly available on registry
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
April 22, 2021
CompletedApril 22, 2021
March 1, 2021
1.7 years
November 30, 2009
March 2, 2021
March 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Flow Rate at First Use After Insertion
First haemodialysis session after insertion
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Tesio Catheter
ACTIVE COMPARATORPatients randomised to receive the established catheter type in use at our centre \[control\]
LifeCath
ACTIVE COMPARATORPatients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)
Interventions
Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access
Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- As above
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
Related Publications (4)
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.
PMID: 15340094BACKGROUNDPerini 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.
PMID: 10751478BACKGROUNDHassell 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.
PMID: 10357479BACKGROUNDPower 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.
PMID: 24500851RESULT
Results Point of Contact
- Title
- Neill Duncan
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Neill Duncan, MBBS MRCP
Imperial College Healthcare NHS Trust
- STUDY DIRECTOR
Albert Power, MBBChir MRCP
Imperial College Healthcare NHS Trust
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2009
First Posted
December 1, 2009
Study Start
October 1, 2008
Primary Completion
July 1, 2010
Study Completion
September 1, 2011
Last Updated
April 22, 2021
Results First Posted
April 22, 2021
Record last verified: 2021-03