Arrow Chloragard Peripherally-Inserted Central Catheters (PICC) Study

March 22, 2017 updated by: Teleflex

A Study to Determine the Incidence of Catheter-Related Venous Thrombosis When Using Arrow Peripherally-Inserted Central Catheters With Chlorag+Ard Technology

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Recruiting
        • University of Kentucky Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Winkler, MD
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Detroit Medical Center
        • Contact:
        • Principal Investigator:
          • John Z Gallien, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body
Other Names:
  • Chloragard PICC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of symptomatic and asymptomatic catheter-related venous thrombosis (CVRT)
Time Frame: within maximum 90 days dwell
within maximum 90 days dwell
Incidence of catheter occlusion
Time Frame: within maximum 90 days dwell
within maximum 90 days dwell
Incidence of catheter-related bloodstream infections
Time Frame: within maximum 90 days dwell
within maximum 90 days dwell

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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