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Completed

NCT Number: NCT03017911

COMPLI-PICC: Study on Picclines' Complications

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest

Brest, 29200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Piccline

Procedure

Primary outcomes

  1. Complication in patient with piccline

    Time frame: 3 month

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Prospective Observational Study on Picclines' Complications at Brest Hospital

Acronym: COMPLI-PICC

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2017
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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