Recruiting

PICC

Sponsor:

Teleflex

Code:

NCT03019302

Conditions

Vascular Access Complication

Vascular Access Related Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Arrow PICC with Chloragard Technology

Study Details

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.

Conditions

Vascular Access Complication

Vascular Access Related Infection

Study ID

NCT03019302

Start date

Dec, 2016

Status verified date

Mar, 2017

Completion date

Sep, 2017

Anticipated

Primary completion date

Aug, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Arrow PICC with Chloragard Technology

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Tatiana Puga

tatiana.puga@teleflex.com

Thomas Philbeck, PhD

thomas.philbeck@teleflex.com

Locations

University of Kentucky Medical Center

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Hossam Elbelasi, MD

Hossam.Elbelasi@uky.edu

Principal Investigator:

Michael Winkler, MD

Detroit Medical Center

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Katee Dawood

kdawood@wayne.edu

Principal Investigator:

John Z Gallien, MD

More Information

Sponsor

Teleflex

Last update posted

Mar 27, 2017

Last verified

Mar, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Teleflex on 2017-03-27.