NCT03017911

COMPLI-PICC: Study on Picclines' Complications

Prospective Observational Study on Picclines' Complications at Brest Hospital

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective monocentric study of PICC Line complications use in 5 medical and one surgical units of Brest Medical University Hospital. To evaluate the incidence of the following complications: infections, thromboses, mechanical and hemorrhagic, at month 3 post-intervention. Also evaluating: * the management of these PICC Line related complications, * risk factors for such complications, * and the mortality-related outcomes.

Detailed description

All eligible patients fulfilling the inclusion criteria, after PICC Line placement, will receive oral and written patient information describing the study deployment and follow-up. Patients will be followed up until PICC Line removal if it occurs during the first 3 months after placement or until death if it occurs during the first 3 months, or during 3 months in the absence of complications. * Infectious complications are described in accordance with IDSA 2009 guidelines and include bloodstream infection, endocarditis, local infection and septic thrombophlebitis. * Thrombotic complications are defined as symptomatic, deep, or superficial venous thrombosis, confirmed by Ultrasound and Echo-Doppler or asymptomatic venous thrombosis diagnosed fortuitously. * Mechanical complications are defined as impairments related to PICC Line device: occlusion, rupture, accidental removal. * Hemorrhagic complications are defined as hematoma or bleedings of puncture site. In the event of PICC Line-related complications, patient will be followed up for an additional 3 months, from the date of complication diagnosis, i.e. maximum follow-up duration of 6 months. Each week during the first month, then once monthly during the follow-up (i.e. W1, W2, W3, W4, M2, M3, +/- M4, M5, M6), all patients data related to the PICC Line retention or removal, use and all its related complications will be collected.

Conditions

• PICC Line Placement

Interventions

Type	Name	Description
PROCEDURE	Piccline

Timeline

• Start date: 2016-10-10
• Primary completion: 2017-05-05
• Completion: 2017-05-05
• First posted: 2017-01-11
• Last updated: 2025-02-06

Locations

1 site across 1 country: France