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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tesio Catheter | Active Comparator | Patients randomised to receive the established catheter type in use at our centre [control] |
|
| LifeCath | Active Comparator | Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TesioCath | Device | Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Flow Rate at First Use After Insertion | First haemodialysis session after insertion |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neill Duncan, MBBS MRCP | Imperial College Healthcare NHS Trust | Principal Investigator |
| Albert Power, MBBChir MRCP | Imperial College Healthcare NHS Trust | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15340094 | Background | 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. | |
| 10751478 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tesio Catheter | Patients randomised to receive the established catheter type in use at our centre [control] TesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access |
| FG001 | LifeCath | Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio) LifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tesio Catheter | Patients randomised to receive the established catheter type in use at our centre [control] TesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access |
| BG001 | LifeCath |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Flow Rate at First Use After Insertion | Posted | Mean | Standard Deviation | mL/min | First haemodialysis session after insertion |
|
Duration of trial, 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tesio Catheter | Patients randomised to receive the established catheter type in use at our centre [control] TesioCath: Insertion of the TesioCath(TM) central venous catheter for haemodialysis vascular access |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sudden cardiac death | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neill Duncan | Imperial College London | +44 (0 )207 594 7243 | n.duncan@imperial.ac.uk |
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| LifeCath Twin | Device | Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access |
|
|
| 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 |
| 10357479 | Background | 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. |
| 24500851 | Result | 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. |
Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio)
LifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Achievement of Flow Rates>=450ml/Min at Dialysis Session | Posted | Mean | Standard Deviation | mL/min | flow rate measured at each session; session at 12 months reported |
|
|
|
| Secondary | Line Retention (Either/Both Lumens) | measure not taken | Posted | 12 months |
|
|
| Secondary | Infective Episodes (Catheter & Non-catheter Related) | measure not collected | Posted | 12 months |
|
|
| Secondary | Catheter Dysfunction Requiring Use of Thrombolytic Agents | Posted | Number | thrombolytic infusions | 12 months |
|
|
|
| Secondary | Complications at Catheter Insertion | Posted | Number | complications at insertion | Day 1 |
|
|
|
| Secondary | Recirculation Rates | measure not taken | Posted | 12 months |
|
|
| 3 |
| 39 |
| 3 |
| 39 |
| 0 |
| 39 |
| EG001 | LifeCath | Patients randomised to receive the LifeCath Twin catheter - the catheter type being compared to the standard line in use at our centre (Tesio) LifeCath Twin: Insertion of the LifeCath Twin central venous catheter for haemodialysis vascular access | 4 | 41 | 4 | 41 | 0 | 41 |
| myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| pulmonary sepsis | Cardiac disorders | Systematic Assessment |
|
| severe hemorrhagic stroke | Cardiac disorders | Systematic Assessment |
|
| metastatic malignancy that was diagnosed 9 months following CVC insertion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
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