Renal Failure Chronic Requiring HemodialysisTDCNCT02685995
VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC
A study testing VectorFlow TDC and Palindrome TDC in people with Renal Failure Chronic Requiring Hemodialysis and Chronic Renal Insufficiency, run by University of Pennsylvania at 2 sites in United States.
Trial summary
Randomized two-arm study examining 90 day primary patency of two FDA-approved tunneled dialysis catheters. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Failure Chronic Requiring Hemodialysis, Chronic Renal Insufficiency
- What is being tested?
- VectorFlow TDC and Palindrome TDC
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2015to Jul 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End stage renal disease or acute renal failure requiring hemodialysis through a tunneled dialysis catheter
- Age >18, Age <80
- Capable of giving informed consent
Who cannot join
- Coagulopathy defined as international normalized ration (INR) >2 which cannot be corrected with fresh frozen plasma
- Platelet count <50,000/microliter, which cannot be corrected with platelet transfusion
- Active skin infections at site of TDC insertion
- Presence of bacteremia or infected AVG/AVF within 7 days prior to enrollment
- Neutropenia defined as absolute neutrophil count less then 1,700/microliter
- Known central venous stenosis
Show all 11Show fewer
- Occlusion of bilateral external and internal jugular veins or bilateral brachiocephalic veins or stenosis of the superior vena cava
- Functioning surgical HD access (ie AVG/AVF) or AVG/AVF which is expected to be functional within 90 days of enrollment
- Inability to provide informed consent
- Pregnant or nursing women
- In the event a physician does not feel that either catheter would be appropriate for a subject, the subject will not be eligible to participate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital of the Unviersity of Pennsylvania
Philadelphia, Pennsylvania, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Randomized Trial Comparing VectorFlow Tunneled Dialysis Catheter to Palindrome Tunneled Dialysis Catheter
Randomized two-arm study examining 90 day primary patency of two FDA-approved tunneled dialysis catheters.
Read the detailed description
The VectorFlow tunneled dialysis catheter is a novel symmetrical tip design tunneled dialysis catheter which in pre-clinical testing and retrospective review has improved flow and patency compared to other dialysis catheter designs. This study will compare 90 day patency rates of newly inserted VF catheters to the Palindrome catheter both of which are FDA approved devices and will inserted as standard of care. The Palindrome catheter has been selected as the comparison device because it is also a symmetrical tip catheter design and prior studies by the manufacturer of this device suggests it has a lower occlusion rate and better flow compared to other catheter designs.
- Being tested
- VectorFlow TDC, Palindrome TDC
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VectorFlow TDCDevice
Also called ARROW-Clark™ VectorFlow™ Hemodialysis Catheter
TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange.
Palindrome TDCDevice
Also called Palindrome™ Dialysis Catheter
TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange.
| Study group | Role | What they receive |
|---|---|---|
| Palindrome TDC | Active comparator | TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange. Receives: Device: Palindrome TDC |
| VectorFlow TDC | Active comparator | TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange. Receives: Device: VectorFlow TDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency - Intervention-free Interval (Measured in Weeks)
The primary study endpoint will be primary patency at 90 days following catheter insertion. Primary patency is defined as an HD catheter which provides adequate hemodialysis (flow >300mL/min) without need for additional interventions (ie TPA infusions or catheter exchange) to maintain flow or correct device failure.
Measured: 30, 60 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal Failure Chronic Requiring HemodialysisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Teleflex, Arrow International
- Responsible party
- Sponsor
- Investigators
- Gregory Nadolski, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685995
- Sponsor's protocol ID
- 823055
- Acronym
- TDC
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2016
- Last updated
- 8 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing VectorFlow Tunneled Dialysis Catheter to Palindrome Tunneled Dialysis Catheter
- ClinicalTrials.gov ID
- NCT02685995
- Acronym / sponsor ID
- TDC / 823055
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Teleflex, Arrow International
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Posted 8 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized two-arm study examining 90 day primary patency of two FDA-approved tunneled dialysis catheters.
Detailed description
The VectorFlow tunneled dialysis catheter is a novel symmetrical tip design tunneled dialysis catheter which in pre-clinical testing and retrospective review has improved flow and patency compared to other dialysis catheter designs. This study will compare 90 day patency rates of newly inserted VF catheters to the Palindrome catheter both of which are FDA approved devices and will inserted as standard of care. The Palindrome catheter has been selected as the comparison device because it is also a symmetrical tip catheter design and prior studies by the manufacturer of this device suggests it has a lower occlusion rate and better flow compared to other catheter designs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palindrome TDC | Active comparator | Device: Palindrome TDCTDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange. |
| VectorFlow TDC | Active comparator | Device: VectorFlow TDCTDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- End stage renal disease or acute renal failure requiring hemodialysis through a tunneled dialysis catheter
- Age >18, Age <80
- Capable of giving informed consent
Key exclusion criteria (11 listed)
- Coagulopathy defined as international normalized ration (INR) >2 which cannot be corrected with fresh frozen plasma
- Platelet count <50,000/microliter, which cannot be corrected with platelet transfusion
- Active skin infections at site of TDC insertion
- Presence of bacteremia or infected AVG/AVF within 7 days prior to enrollment
- Neutropenia defined as absolute neutrophil count less then 1,700/microliter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VectorFlow TDCAlso: ARROW-Clark™ VectorFlow™ Hemodialysis CatheterTDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange. | Device | VectorFlow TDC |
| Palindrome TDCAlso: Palindrome™ Dialysis CatheterTDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange. | Device | Palindrome TDC |
Primary outcome
Primary Patency - Intervention-free Interval (Measured in Weeks)
Time frame: 30, 60 and 90 days
The primary study endpoint will be primary patency at 90 days following catheter insertion. Primary patency is defined as an HD catheter which provides adequate hemodialysis (flow >300mL/min) without need for additional interventions (ie TPA infusions or catheter exchange) to maintain flow or correct device failure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Vectorlow Dialysis Catheter Product InformationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Nadolski, MD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VectorFlow TDC and Palindrome TDC in people with Renal Failure Chronic Requiring Hemodialysis and Chronic Renal Insufficiency, run by University of Pennsylvania at 2 sites in United States.
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 3 inclusion and 11 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 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 8 Feb 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?
Primary Patency - Intervention-free Interval (Measured in Weeks) (time frame: 30, 60 and 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2021.