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COMPLI-PICC: Study on Picclines' Complications (COMPLI-PICC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017911
Recruitment Status : Unknown
Verified October 2016 by University Hospital, Brest.
Recruitment status was:  Recruiting
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
PICC Line Placement Procedure: Piccline

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study on Picclines' Complications at Brest Hospital
Study Start Date : October 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Group/Cohort Intervention/treatment
Patients with PICC Lines
All patients included in this study have undergone PICC Line placement before enrollment.
Procedure: Piccline



Primary Outcome Measures :
  1. Complication in patient with piccline [ Time Frame: 3 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients > 18 yo from internal medicine, pneumology, nutrition, oncology, hematology, and cardiac and vascular surgery - who underwent PICC Line placement between October 10, 2016 and March 9, 2017 will be included in the study.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017911


Contacts
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Contact: Claire DE MOREUIL claire.demoreuil@chu-brest.fr

Locations
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France
CHRU de Brest Recruiting
Brest, France, 29200
Contact: Claire de Moreuil, M.D.    0298145303    claire.demoreuil@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest
Publications:

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03017911    
Other Study ID Numbers: COMPLI-PICC
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Brest:
PICC Line
Complications
Thrombosis
Infection