- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03019302
Arrow Chloragard Peripherally-Inserted Central Catheters (PICC) Study
March 22, 2017 updated by: Teleflex
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tatiana Puga
- Email: tatiana.puga@teleflex.com
Study Contact Backup
- Name: Thomas Philbeck, PhD
- Email: thomas.philbeck@teleflex.com
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40506
- Recruiting
- University of Kentucky Medical Center
-
Contact:
- Hossam Elbelasi, MD
- Email: Hossam.Elbelasi@uky.edu
-
Principal Investigator:
- Michael Winkler, MD
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Recruiting
- Detroit Medical Center
-
Contact:
- Katee Dawood
- Email: kdawood@wayne.edu
-
Principal Investigator:
- John Z Gallien, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of symptomatic and asymptomatic catheter-related venous thrombosis (CVRT)
Time Frame: within maximum 90 days dwell
|
within maximum 90 days dwell
|
Incidence of catheter occlusion
Time Frame: within maximum 90 days dwell
|
within maximum 90 days dwell
|
Incidence of catheter-related bloodstream infections
Time Frame: within maximum 90 days dwell
|
within maximum 90 days dwell
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Anticipated)
August 1, 2017
Study Completion (Anticipated)
September 1, 2017
Study Registration Dates
First Submitted
January 11, 2017
First Submitted That Met QC Criteria
January 11, 2017
First Posted (Estimate)
January 12, 2017
Study Record Updates
Last Update Posted (Actual)
March 27, 2017
Last Update Submitted That Met QC Criteria
March 22, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 2015-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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