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Upper Extremity Deep Vein ThrombosisPICC/MIDLINENCT02489721

Major Complications Related to PICC and Midline Insertion

An observational study of Upper Extremity Deep Vein Thrombosis, run by Azienda Ospedaliera S. Maria della Misericordia at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Upper Extremity Deep Vein Thrombosis
What is being tested?
PICC and Midline
Type of treatment
Medical device
How many people
547 participants
Where
1 siteItaly
Study dates
Jun 2015to Jan 2020
How long will I take part?
2 Years
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • AOU Santa Maria della Misericordia

    Udine, 33100

Other trials in Italy

About this study

Official title: PICC and Midline Related Complications: A Multicenter Observational Study

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.

Being tested
PICC and Midline
Keywords
peripherally inserted central venous catheter, depp vein thrombosis, related blood stream infections, midline
Medical subject headings
Upper Extremity Deep Vein Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PICC and MidlineDevice

    Peripherally inserted central venous catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 2 years

Secondary outcomes (4)
  1. Prevalence of infections related catheter

    Measured: 2 years

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

    Measured: 2 years

  3. Reason of the catheter removal

    Measured: 2 years

  4. Prevalence of the same complications Midline related

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionJan 2020
  4. Study completionJan 2020

Resources

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
547 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02489721
Sponsor's protocol ID
PICC/MIDLINE1
Acronym
PICC/MIDLINE
Status last verified
Jan 2020
First submitted
30 Jun 2015
Last updated
13 Jan 2020
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Upper Extremity Deep Vein Thrombosis, run by Azienda Ospedaliera S. Maria della Misericordia at 1 site in Italy.

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 1 inclusion and 6 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 13 Jan 2020. 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 Italy. 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?

Prevalence of deep venous thrombosis (DVT) occurring after the PICC placement in all patients (time frame: 2 years). 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 NCT02489721, which also lists 2 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 13 Jan 2020.

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