Clinical trial NCT03019302: Arrow Chloragard Peripherally-Inserted Central Catheters (PICC) 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vascular Access Complication
Vascular Access Related Infection
Lead sponsor: Teleflex
Sponsor class: INDUSTRY
Collaborators: name: Arrow International
First posted: 2017-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of symptomatic and asymptomatic catheter-related venous thrombosis (CVRT)
timeFrame: within maximum 90 days dwell
measure: Incidence of catheter occlusion
timeFrame: within maximum 90 days dwell
measure: Incidence of catheter-related bloodstream infections
timeFrame: within maximum 90 days dwell
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Detroit
country: United States
facility: Detroit Medical Center
state: Michigan
Study officials:
References: