COMPLI-PICC: Study on Picclines' Complications (COMPLI-PICC)
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|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
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.
- 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|
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 Type :||Observational|
|Estimated Enrollment :||120 participants|
|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|
Patients with PICC Lines
All patients included in this study have undergone PICC Line placement before enrollment.
- Complication in patient with piccline [ Time Frame: 3 month ]
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
|Contact: Claire DE MOREUILfirstname.lastname@example.org|
|CHRU de Brest||Recruiting|
|Brest, France, 29200|
|Contact: Claire de Moreuil, M.D. 0298145303 email@example.com|