Vascular Access ComplicationNCT03019302
Arrow Chloragard Peripherally-Inserted Central Catheters (PICC) Study
A study testing Arrow PICC with Chloragard Technology in people with Vascular Access Complication and Vascular Access Related Infection, run by Teleflex at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication, Vascular Access Related Infection
- What is being tested?
- Arrow PICC with Chloragard Technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Tatiana Puga contact
Thomas Philbeck, PhD contact
United States2 sites, 2 recruiting
- Recruiting
Detroit Medical Center
Detroit, Michigan, 48201
Katee Dawood, kdawood@wayne.edu
John Z Gallien, MD
- Recruiting
University of Kentucky Medical Center
Lexington, Kentucky, 40506
Hossam Elbelasi, MD, Hossam.Elbelasi@uky.edu
Michael Winkler, MD
About this study
Official title: 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.
- Being tested
- Arrow PICC with Chloragard Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arrow PICC with Chloragard TechnologyDevice
Also called Chloragard PICC
chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body
| Study group | Role | What they receive |
|---|---|---|
| Arrow PICC with Chloragard Technology | Experimental | 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. Receives: Device: Arrow PICC with Chloragard Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic and asymptomatic catheter-related venous thrombosis (CVRT)
Measured: within maximum 90 days dwell
Incidence of catheter occlusion
Measured: within maximum 90 days dwell
Incidence of catheter-related bloodstream infections
Measured: within maximum 90 days dwell
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teleflex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arrow International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019302
- Sponsor's protocol ID
- 2015-07
- Status last verified
- Mar 2017
- First submitted
- 11 Jan 2017
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Incidence of Catheter-Related Venous Thrombosis When Using Arrow Peripherally-Inserted Central Catheters With Chlorag+Ard Technology
- ClinicalTrials.gov ID
- NCT03019302
- Acronym / sponsor ID
- 2015-07
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- TeleflexIndustry (pharma, biotech, devices)
- Collaborators
- Arrow International
- Study start
- Dec 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arrow PICC with Chloragard Technology | Experimental | Device: Arrow PICC with Chloragard TechnologyArrow 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arrow PICC with Chloragard TechnologyAlso: Chloragard PICCchlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body | Device | Arrow PICC with Chloragard Technology |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatiana Puga contact
Thomas Philbeck, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arrow PICC with Chloragard Technology in people with Vascular Access Complication and Vascular Access Related Infection, run by Teleflex at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Puga (tatiana.puga@teleflex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic and asymptomatic catheter-related venous thrombosis (CVRT) (time frame: within maximum 90 days dwell). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017; AzTrials last refreshed its copy on 28 Oct 2026.