CClinicalTrials.gg
Status unknownNCT03019302Updated Mar 27, 2017

Arrow Chloragard Peripherally-Inserted Central Catheters (PICC) Study

An interventional study of Arrow PICC with Chloragard Technology in Vascular Access Complication and Vascular Access Related Infection, sponsored by Teleflex. Status unknown at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-27.

Sponsored by Teleflex · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

A prospective study evaluating the timing, incidence and relationship of commonly occurring complications related to the use of peripherally-inserted central catheters. All subjects will receive PICC access using the Arrow PICC with Chloragard Technology.

02

Conditions studied

  • Vascular Access Complication
  • Vascular Access Related Infection
03

In context

Lead sponsor

Teleflex is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients age ≥ 18 years requiring a PICC for a period of fourteen days or greater (note: maximum study period is 90 days)
  • Ability to comply with study requirements inclusive of the follow-up duplex ultrasound procedures and, as applicable, recording of PICC management, interventions and related treatments in the inpatient and outpatient setting in the daily subject diary
  • Patients cognitively and physically able to give written consent to participate in the study or patient has a legally authorized representative (LAR) who may give written consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Previous history of (within 3 months) or current diagnosis of venous thrombosis within the venous tract of the proposed catheter
  • History or diagnosis of peripheral or central vein stenosis (on proposed insertion side)
  • History or diagnosis of veno-occlusive disease
  • History or diagnosis of superior vena cava syndrome
  • Known, pre-existing diagnosis of hypercoagulation disorder unrelated to underlying disease
  • Previous enrollment in this study
  • Currently pregnant or breast feeding
  • Previous axillary lymph node dissection on the same side as intended catheter insertion site unless cleared by physician and patient consent
  • Skin condition at or within 15 cm of the proposed catheter insertion site, including signs and symptoms of inflammation, rash, crusts, wounds with drainage, sites of intravenous infusion infiltration or extravasation, hematoma, phlebitis and or thrombophlebitis
  • Medical, social, and/or psychological problems precluding subject from study participation
  • Stage 2, 3 or 4 chronic kidney disease or serum creatinine > 3 mg/dl or Glomerular Filtration Rate (GFR) less than 60 mL per minute per 1.73 m2 unless cleared by a nephrologist for participation
  • Known allergy or sensitivity to chlorhexidine
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Arrow PICC with Chloragard Technology

    Arrow Peripherally- Inserted Central Catheters with Chloragard Technology. The application of Chlorag+ard® Technology uses a proprietary process whereby chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body.

    Device: Arrow PICC with Chloragard Technology

Interventions

  • DeviceArrow PICC with Chloragard Technology

    chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body

    Also known as: Chloragard PICC

06

What researchers measure

Primary outcomes

  1. Incidence of symptomatic and asymptomatic catheter-related venous thrombosis (CVRT)

    Time frame: within maximum 90 days dwell

  2. Incidence of catheter occlusion

    Time frame: within maximum 90 days dwell

  3. Incidence of catheter-related bloodstream infections

    Time frame: within maximum 90 days dwell

07

Study locations

2 of 2 sites recruiting
  • University of Kentucky Medical Center
    Lexington, Kentucky 40506, United States
    Recruiting
  • Detroit Medical Center
    Detroit, Michigan 48201, United States
    • Katee Dawood · Contact · kdawood@wayne.edu
    • John Z Gallien, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03019302
Lead sponsor
Teleflex
Collaborators
Arrow International
Responsible party
Sponsor
First posted
Jan 12, 2017
Start date
Dec 2016
Primary completion
Aug 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Mar 27, 2017

Study contacts

Tatiana Puga
Contact
tatiana.puga@teleflex.com
Thomas Philbeck, PhD
Contact
thomas.philbeck@teleflex.com

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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