NCT03019302

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

January 11, 2017

Last Update Submit

March 22, 2017

Conditions

Vascular Access ComplicationVascular Access Related Infection

Outcome Measures

Primary Outcomes (3)

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

    within maximum 90 days dwell

  • Incidence of catheter occlusion

    within maximum 90 days dwell

  • Incidence of catheter-related bloodstream infections

    within maximum 90 days dwell

Study Arms (1)

Arrow PICC with Chloragard Technology

EXPERIMENTAL

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

Arrow PICC with Chloragard TechnologyDEVICE

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

Also known as: Chloragard PICC
Arrow PICC with Chloragard Technology

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kentucky Medical Center

Lexington, Kentucky, 40506, United States

RECRUITING

Detroit Medical Center

Detroit, Michigan, 48201, United States

RECRUITING

Central Study Contacts

Tatiana Puga

CONTACT

tatiana.puga@teleflex.com

Thomas Philbeck, PhD

CONTACT

thomas.philbeck@teleflex.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 12, 2017

Study Start

December 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

March 27, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)