Arrow Chloragard Peripherally-Inserted Central Catheters (PICC) Study

Vascular Access Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03019302
• Other study ID #: 2015-07
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2017
• Last updated: March 22, 2017
• Start date: December 2016
• Est. completion date: September 2017

Study information

• Verified date: March 2017
• Source: Teleflex
• Contact: Tatiana Puga
• Email: tatiana.puga[@]teleflex.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Access Complication
• Vascular Access Related Infection

Intervention

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

Locations

Country	Name	City	State
United States	Detroit Medical Center	Detroit	Michigan
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Teleflex	Arrow International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of symptomatic and asymptomatic catheter-related venous thrombosis (CVRT)		within maximum 90 days dwell
Primary	Incidence of catheter occlusion		within maximum 90 days dwell
Primary	Incidence of catheter-related bloodstream infections		within maximum 90 days dwell