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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01022359
First Posted: December 1, 2009
Last Update Posted: May 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust
November 30, 2009
December 1, 2009
May 13, 2016
October 2008
July 2010   (Final data collection date for primary outcome measure)
Achieving a blood flow rate>=450ml/min at first use after insertion [ Time Frame: First haemodialysis session after insertion ]
Same as current
Complete list of historical versions of study NCT01022359 on ClinicalTrials.gov Archive Site
  • Achievement of flow rates>=450ml/min at each dialysis session [ Time Frame: 12 months ]
  • Line retention (either/both lumens) [ Time Frame: 12 months ]
  • Infective episodes (catheter & non-catheter related) [ Time Frame: 12 months ]
  • Catheter dysfunction requiring use of thrombolytic agents [ Time Frame: 12 months ]
  • Complications at catheter insertion [ Time Frame: Day 1 ]
  • Recirculation rates [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters
Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hemodialysis
  • Device: TesioCath
    Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access
    Other Name: BioFlex TesioCath (TM) - MedComp, Harleysville, PA, USA
  • Device: LifeCath Twin
    Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access
    Other Name: Vygon LifeCath Twin - Vygon(UK) Ltd, Cirencester, Gloucs, UK
  • Active Comparator: Tesio Catheter
    Patients randomised to receive the established catheter type in use at our centre [control]
    Intervention: Device: TesioCath
  • 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)
    Intervention: Device: LifeCath Twin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
September 2011
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01022359
08/H0710/24
No
Not Provided
Not Provided
Imperial College Healthcare NHS Trust
Imperial College Healthcare NHS Trust
Not Provided
Principal Investigator: Neill Duncan, MBBS MRCP Imperial College Healthcare NHS Trust
Study Director: Albert Power, MBBChir MRCP Imperial College Healthcare NHS Trust
Imperial College Healthcare NHS Trust
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP