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Arrow Chloragard Peripherally-Inserted Central Catheters (PICC) Study

Sponsor
Teleflex (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03019302
Collaborator
Arrow International (Industry)
100
Enrollment
2
Locations
1
Arm
9
Duration (Months)
50
Patients Per Site
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Arrow PICC with Chloragard Technology
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Study to Determine the Incidence of Catheter-Related Venous Thrombosis When Using Arrow Peripherally-Inserted Central Catheters With Chlorag+Ard Technology
Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Aug 1, 2017
Anticipated Study Completion Date :
Sep 1, 2017

Arms and Interventions

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.

Device: Arrow PICC with Chloragard Technology
chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body
Other Names:
  • Chloragard PICC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of symptomatic and asymptomatic catheter-related venous thrombosis (CVRT) [within maximum 90 days dwell]

    2. Incidence of catheter occlusion [within maximum 90 days dwell]

    3. Incidence of catheter-related bloodstream infections [within maximum 90 days dwell]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kentucky Medical Center Lexington Kentucky United States 40506
    2 Detroit Medical Center Detroit Michigan United States 48201

    Sponsors and Collaborators

    • Teleflex
    • Arrow International

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Teleflex
    ClinicalTrials.gov Identifier:
    NCT03019302
    Other Study ID Numbers:
    • 2015-07
    First Posted:
    Jan 12, 2017
    Last Update Posted:
    Mar 27, 2017
    Last Verified:
    Mar 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Mar 27, 2017