Arrow Chloragard Peripherally-Inserted Central Catheters (PICC) Study

Not Applicable

• Conditions: Vascular Access Complication; Vascular Access Related Infection
• Interventions: Device: Arrow PICC with Chloragard Technology

• Registration Number: NCT03019302
• Lead Sponsor: Teleflex

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-27
• Primary Completion: 2017-08
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arrow PICC with Chloragard Technology	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Detroit Medical Center; 🇺🇸 Detroit, Michigan, United States

University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States