PICC Line PlacementCOMPLI-PICCNCT03017911
COMPLI-PICC: Study on Picclines' Complications
An observational study of PICC Line Placement, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PICC Line Placement
- What is being tested?
- Piccline
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2016to 5 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients hospitalized in other units than those cited above
- Patients verbal refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study on Picclines' Complications at Brest Hospital
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.
Read the 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.
- Conditions
- PICC Line Placement
- Being tested
- Piccline
- Keywords
- PICC Line, Complications, Thrombosis, Infection
- Medical subject headings
- Thrombosis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicclineProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with PICC Lines | All patients included in this study have undergone PICC Line placement before enrollment. Receives: Procedure: Piccline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication in patient with piccline
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start10 Oct 2016
- Primary completion5 May 2017
- Study completion5 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PICC Line PlacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017911
- Sponsor's protocol ID
- COMPLI-PICC
- Acronym
- COMPLI-PICC
- Status last verified
- Feb 2025
- First submitted
- 10 Jan 2017
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376.
PubMed 19489710O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
PubMed 21511081Safdar N, Maki DG. Risk of catheter-related bloodstream infection with peripherally inserted central venous catheters used in hospitalized patients. Chest. 2005 Aug;128(2):489-95. doi: 10.1378/chest.128.2.489.
PubMed 16100130Chopra V, Ratz D, Kuhn L, Lopus T, Chenoweth C, Krein S. PICC-associated bloodstream infections: prevalence, patterns, and predictors. Am J Med. 2014 Apr;127(4):319-28. doi: 10.1016/j.amjmed.2014.01.001. Epub 2014 Jan 17.
PubMed 24440542Chemaly RF, de Parres JB, Rehm SJ, Adal KA, Lisgaris MV, Katz-Scott DS, Curtas S, Gordon SM, Steiger E, Olin J, Longworth DL. Venous thrombosis associated with peripherally inserted central catheters: a retrospective analysis of the Cleveland Clinic experience. Clin Infect Dis. 2002 May 1;34(9):1179-83. doi: 10.1086/339808. Epub 2002 Apr 3.
PubMed 11941543Vidal V, Muller C, Jacquier A, Giorgi R, Le Corroller T, Gaubert J, Champsaur P, Bartoli J, Moulin G. [Prospective evaluation of PICC line related complications]. J Radiol. 2008 Apr;89(4):495-8. doi: 10.1016/s0221-0363(08)71453-7. French.
PubMed 18477956
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on Picclines' Complications at Brest Hospital
- ClinicalTrials.gov ID
- NCT03017911
- Acronym / sponsor ID
- COMPLI-PICC / COMPLI-PICC
- Conditions
- PICC Line Placement
- Keywords
- PICC Line, Complications, Thrombosis, Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 5 May 2017 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PICC Lines | – | Procedure: PicclineAll patients included in this study have undergone PICC Line placement before enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients hospitalized in other units than those cited above
- Patients verbal refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piccline | Procedure or surgery | Patients with PICC Lines |
Primary outcome
Complication in patient with piccline
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 19489710Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376.
- Background: PubMed 21511081O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
- Background: PubMed 16100130Safdar N, Maki DG. Risk of catheter-related bloodstream infection with peripherally inserted central venous catheters used in hospitalized patients. Chest. 2005 Aug;128(2):489-95. doi: 10.1378/chest.128.2.489.
- Background: PubMed 24440542Chopra V, Ratz D, Kuhn L, Lopus T, Chenoweth C, Krein S. PICC-associated bloodstream infections: prevalence, patterns, and predictors. Am J Med. 2014 Apr;127(4):319-28. doi: 10.1016/j.amjmed.2014.01.001. Epub 2014 Jan 17.
- Background: PubMed 11941543Chemaly RF, de Parres JB, Rehm SJ, Adal KA, Lisgaris MV, Katz-Scott DS, Curtas S, Gordon SM, Steiger E, Olin J, Longworth DL. Venous thrombosis associated with peripherally inserted central catheters: a retrospective analysis of the Cleveland Clinic experience. Clin Infect Dis. 2002 May 1;34(9):1179-83. doi: 10.1086/339808. Epub 2002 Apr 3.
- Background: PubMed 18477956Vidal V, Muller C, Jacquier A, Giorgi R, Le Corroller T, Gaubert J, Champsaur P, Bartoli J, Moulin G. [Prospective evaluation of PICC line related complications]. J Radiol. 2008 Apr;89(4):495-8. doi: 10.1016/s0221-0363(08)71453-7. French.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PICC Line Placement, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication in patient with piccline (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03017911, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.