Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT03019302
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03019302
Study Brief:
Protocol Section:
NCT03019302