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CompletedNCT02489721PICC/MIDLINEUpdated Jan 13, 2020

Major Complications Related to PICC and Midline Insertion

An observational study in Upper Extremity Deep Vein Thrombosis, sponsored by Azienda Ospedaliera S. Maria della Misericordia. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by Azienda Ospedaliera S. Maria della Misericordia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
547
Ages
18 Years to 90 Years
Sex
All
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Study summary

Most important peripherally inserted central catheter (PICC) and Midline complications are thrombosis and catheter related blood stream infections. No large prospective observational study are present in literature about these topics. The aim of this multicenter prospective observational study is to analyze all the complications due to PICC and Midline insertion.

Read the detailed description

A PICC line is a Peripherally Inserted Central Catheter. It is long, small, flexible tube that is inserted into a peripheral vein, typically in the upper arm, and terminates in a large vein in the chest to obtain a central intravenous access. A Midline catheter is similar to a PICC, but it is shorter in length (about 25 cm) and is inserted into a large vein in the upper arm, terminating not beyond the axillary vein. Midline catheters offer a longer dwell time and better hemodilution than the short peripheral IV catheters.The use of PICC and Midline has been increasing in outpatient and inpatient settings. Factors driving this increased use include their ease of insertion due to the placement into a peripheral vein-a safer approach-with the benefit of a central tip location appropriate for any osmolarity and pH infusions, a low reported incidence of infection, a better patient comfort, a durable venous access, and an easier nursing management in outpatient setting. PICC placement under ultrasound guidance can be carried out with no iatrogenic, mechanical complications associated with central venous catheter insertion in the neck or chest (pneumothorax, hemothorax etc...). Despite their many advantages, recent data suggest that PICCs are associated with venous thromboembolism. The incidence of symptomatic thrombosis ranges from 1.9% to 8.4% and it increases to 75% considering also the asymptomatic one. The risk factors that predispose a patient to the development of a thrombotic complication are: the caliber of the device (≥5Fr), the position of the catheter tip, the insertion of the PICC in a paretic limb, a history of venous thrombosis, the residence time of the device and the presence of an oncological pathology. The second major complication due to the PICC insertion is the catheter related blood stream infection (CRBSI). The incidence of PICC-BSI in literature ranges from 2.0 per 1000 catheter days to 3.1 per 1000 catheter days. This disparity stems from the fact that there is no single definition of catheter infection. Multiple factors associated with patient and catheter care have been identified has having an increased risk of CRBSI and are amenable to preventive measures. Independent risk factors for PICC BSIs included congestive heart failure, intrabdominal perforation, Clostridium difficile infection, recent chemotherapy, presence of tracheostomy, and type of catheter (double or tri lumen). Limited data exists regard prospective observational study on deep vein thrombosis and CRBSI related to PICC and Midline insertion, including the different calibers of the device and the presence of single or multiple lumen.

The investigators designed a multicenter prospective observational study to determine the incidence of deep vein thrombosis, related/associated catheter blood stream infections and the incidence of all the minor complications due to PICC and Midline insertion.

02

Conditions studied

  • Upper Extremity Deep Vein Thrombosis

Keywords

  • peripherally inserted central venous catheter
  • depp vein thrombosis
  • related blood stream infections
  • midline
03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 547 is above the median of 213 across 586 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Azienda Ospedaliera S. Maria della Misericordia is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study will be conducted in all the patients undergoing PICC or Midline catheter insertion which fall in the inclusion criteria

Inclusion criteria

  • all patients aged 18-90 years (oncological, malignancy hematology, medical, surgical and critically ICU patients) in whom it was determined that PICC/Midline insertion was indicated.

Exclusion criteria

Exclusion Criteria:

  • renal insufficiency whose creatinine level was greater than 3.0 mg/dL or who were undergoing hemodialysis,
  • preexisting bacteremia (ie, existing positive blood cultures that had not been repeated with negative results);
  • preexisting venous thrombosis or known hypercoagulable states (such as protein C or S deficiency, Antithrombin deficiency, lupus anticoagulant);
  • axillary lymphonodi dissection or alteration of lymphatic drainage;
  • PICC and/or Midline insertion in a paretic arm;
  • patients who had been previously enrolled in the trial.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
547 participants (actual)
Target follow-up
2 Years
Patient registry
Yes

Interventions

  • DevicePICC and Midline

    Peripherally inserted central venous catheter

06

What researchers measure

Primary outcomes

  1. Prevalence of deep venous thrombosis (DVT) occurring after the PICC placement in all patients

    Time frame: 2 years

Secondary outcomes

  1. Prevalence of infections related catheter

    Time frame: 2 years

  2. Prevalence of other complications such as phlebitis, occlusion, malposition

    Time frame: 2 years

  3. Reason of the catheter removal

    Time frame: 2 years

  4. Prevalence of the same complications Midline related

    Time frame: 2 years

07

Study locations

1 site
  • AOU Santa Maria della Misericordia
    Udine, 33100, Italy
08

References and documents

Publications

  • Greene MT, Flanders SA, Woller SC, Bernstein SJ, Chopra V. The Association Between PICC Use and Venous Thromboembolism in Upper and Lower Extremities. Am J Med. 2015 Sep;128(9):986-93.e1. doi: 10.1016/j.amjmed.2015.03.028. Epub 2015 May 1. PubMed 25940453 ↗
  • Chopra V, Fallouh N, McGuirk H, Salata B, Healy C, Kabaeva Z, Smith S, Meddings J, Flanders SA. Patterns, risk factors and treatment associated with PICC-DVT in hospitalized adults: A nested case-control study. Thromb Res. 2015 May;135(5):829-34. doi: 10.1016/j.thromres.2015.02.012. Epub 2015 Feb 21. PubMed 25726426 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02489721
Lead sponsor
Azienda Ospedaliera S. Maria della Misericordia
Responsible party
Livia Pompei (Medical Doctor, Azienda Ospedaliera S. Maria della Misericordia) — Principal investigator
First posted
Jul 3, 2015
Start date
Jun 2015
Primary completion
Jan 2020
Completion
Jan 2020
Last update
Jan 13, 2020

Study contacts

Livia Pompei, MD
principal investigator · AOU Santa Maria della Misericordia
Giorgio Della Rocca, MD
study director · AOU Santa Maria della Misericordia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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