Arrow Chloragard Peripherally-Inserted Central Catheters (PICC) Study
Status unconfirmed · Not applicable
Conditions studied: Vascular Access Complication, Vascular Access Related Infection
In brief
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.
Key facts
- Study ID
- NCT03019302
- Run by
- Teleflex
- People needed
- 100
- Starts
- 2016-12-01
- Expected to finish
- 2017-09-01
- Last updated by the study team
- 2017-03-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Kentucky Medical Center — Lexington, Kentucky, United States (enrolling)
- Detroit Medical Center — Detroit, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
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