COMPLI-PICC: Study on Picclines' Complications

Completed

• Conditions: PICC Line Placement
• Interventions: Procedure: Piccline

• Registration Number: NCT03017911
• Lead Sponsor: University Hospital, Brest

Brief 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.

Study Timeline

• Study Start: 2016-10-10
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-11
• Primary Completion: 2017-05-05
• Study Completion: 2017-05-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patient > 18 yo
• Patients > 18 yo hospitalized in internal medicine, pneumology, nutrition, oncology, hematology, and cardiac and vascular surgery - who underwent PICC Line placement between October 10, 2016 and March 9, 2017

Exclusion Criteria

• Patients hospitalized in other units than those cited above
• Patients verbal refusal to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with PICC Lines	Piccline	All patients included in this study have undergone PICC Line placement before enrollment.

Primary Outcome Measures

Name	Time	Method
Complication in patient with piccline	3 month

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France