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.
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.
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.
- Conditions
- Upper Extremity Deep Vein Thrombosis
- 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.
Prevalence of deep venous thrombosis (DVT) occurring after the PICC placement in all patients
Measured: 2 years
Secondary outcomes (4)
Prevalence of infections related catheter
Measured: 2 years
Prevalence of other complications such as phlebitis, occlusion, malposition
Measured: 2 years
Reason of the catheter removal
Measured: 2 years
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.
- First posted3 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity Deep Vein ThrombosisStudies 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
- 547 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera S. Maria della Misericordia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livia Pompei, Azienda Ospedaliera S. Maria della Misericordia
- Investigators
- Livia Pompei, MD, Principal investigator, AOU Santa Maria della MisericordiaGiorgio Della Rocca, MD, Study director, AOU Santa Maria della Misericordia
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 25940453Chopra 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PICC and Midline Related Complications: A Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT02489721
- Acronym / sponsor ID
- PICC/MIDLINE / PICC/MIDLINE1
- Conditions
- Upper Extremity Deep Vein Thrombosis
- Keywords
- peripherally inserted central venous catheter, depp vein thrombosis, related blood stream infections, midline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- Azienda Ospedaliera S. Maria della MisericordiaUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 3 Jul 2015 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| PICC and MidlinePeripherally inserted central venous catheter | Device | – |
Primary outcome
Prevalence of deep venous thrombosis (DVT) occurring after the PICC placement in all patients
Time frame: 2 years
4 secondary outcomes
Prevalence of infections related catheter
Time frame: 2 years
Prevalence of other complications such as phlebitis, occlusion, malposition
Time frame: 2 years
Reason of the catheter removal
Time frame: 2 years
Prevalence of the same complications Midline related
Time frame: 2 years
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 13 Jan 2020.
- Results publication: PubMed 25940453Greene 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.
- Results publication: PubMed 25726426Chopra 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.
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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.
Livia Pompei, MD principal investigator
AOU Santa Maria della Misericordia
Giorgio Della Rocca, MD study director
AOU Santa Maria della Misericordia
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 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.