VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC

Study Overview
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Brief Summary
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Randomized two-arm study examining 90 day primary patency of two FDA-approved tunneled dialysis catheters.

Detailed Description
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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.

Official Title
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Randomized Trial Comparing VectorFlow Tunneled Dialysis Catheter to Palindrome Tunneled Dialysis Catheter

Conditions
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Renal Failure Chronic Requiring Hemodialysis, Chronic Renal Insufficiency

Intervention / Treatment
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* Device: VectorFlow TDC
* Device: Palindrome TDC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: End stage renal disease or acute renal failure requiring hemodialysis through a tunneled dialysis catheter Age >18, Age <80 Capable of giving informed consent Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Palindrome TDC<br>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. | Device: Palindrome TDC<br>* 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.<br>* Other names: Palindrome™ Dialysis Catheter;|
| Active Comparator: VectorFlow TDC<br>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. | Device: VectorFlow TDC<br>* 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.<br>* Other names: ARROW-Clark™ VectorFlow™ Hemodialysis Catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30, 60 and 90 days |