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COMPLI-PICC: Study on Picclines' Complications

Prospective Observational Study on Picclines' Complications at Brest Hospital

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03017911
Acronym
COMPLI-PICC
Enrollment
120
Registered
2017-01-11
Start date
2016-10-10
Completion date
2017-05-05
Last updated
2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PICC Line Placement

Keywords

PICC Line, Complications, Thrombosis, Infection

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.

Interventions

PROCEDUREPiccline

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Complication in patient with piccline3 month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026