Arrow Chloragard Peripherally-Inserted Central Catheters (PICC) Study



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:1/14/2017
Start Date:December 2016
End Date:September 2017
Contact:Tatiana Puga
Email:tatiana.puga@teleflex.com

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

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.


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
We found this trial at
2
sites
Detroit, Michigan 48201
Principal Investigator: John Z Gallien, MD
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from
Detroit, MI
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740 South Limestone Street
Lexington, Kentucky 40536
Principal Investigator: Michael Winkler, MD
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from
Lexington, KY
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