Status:
UNKNOWN
Comparing Arrow PICC Catheters w/ Arrowga+rd Blue Advanced Protection Performance and Safety to Unprotected PICC's
Lead Sponsor:
Teleflex
Conditions:
Peripherally Inserted Central Catheter
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study seeks to compare the standard unprotected PICC with the AGBA PICC for placement success, incidence of venous thrombosis through duplex ultrasound, observing for signs and symptoms of thromb...
Detailed Description
The primary purpose of this study is to prospectively collect outcome data in order to evaluate the performance and safety of the Arrowga+rd Blue Advanced PICC with regard to first attempt insertion s...
Eligibility Criteria
Inclusion
- Patients age ≥ 18 years requiring a PICC
- Patient will remain an inpatient for the entire dwell time
- Ability to comply with study requirements of duplex ultrasound procedures prior to and at the time of PICC removal
- 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
- Current diagnosis of venous thrombosis within the venous tract of the proposed catheter
- Diagnosis of peripheral or central vein stenosis (on proposed insertion side)
- History or diagnosis of veno-occlusive disease
- 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
- 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
- Known allergy or sensitivity to chlorhexidine
Key Trial Info
Start Date :
January 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
444 Patients enrolled
Trial Details
Trial ID
NCT05278507
Start Date
January 16 2020
End Date
June 30 2023
Last Update
January 23 2023
Active Locations (5)
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1
Beijing Hospital
Beijing, Doncheng District, China, 100730
2
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Fengtai District, China, 100039
3
Peking University Third Hospital
Beijing, Haidian District, China, 100191
4
The First Medical Center of Chinese PLA General Hospital
Beijing, Haidian District, China, 100853