CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
VectorFlow TDC +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02685995
NCT02685995N/ACompleted
CompareCT.gov

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

University of Pennsylvania·interventional·Posted Feb 19, 2016·Updated Feb 8, 2021

In Brief

A clinical study evaluating VectorFlow TDC and Palindrome TDC for Renal Failure Chronic Requiring Hemodialysis and Chronic Renal Insufficiency. Completed, enrolled 100 participants across 2 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Failure Chronic Requiring Hemodialysis, Chronic Renal Insufficiency
CountriesUnited States
CollaboratorsTeleflex, Arrow International

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 19, 2016
Enrollment StartDec 1, 2015
Primary CompletionDec 1, 2019
Study CompletionJul 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 10.4 years ago

Interventions

VectorFlow TDCdevice

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

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.