Venous ThrombosisDVT-PICCNCT02752984
Study on the Incidence of Early Deep Vein Thrombosis After Peripherally Inserted Central Catheter Insertion
An observational study of Venous Thrombosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Deep Vein Thrombosis (DVT) is one of the most important complications after Peripherally Inserted Central Catheter (PICC) insertion. This study goals are to understand when and why DVT develops. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Thrombosis
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2016to Jun 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with Peripherally Inserted Central Catheter insertion
Who may be able to join
- Peripherally Inserted Central Catheter insertion
Who cannot join
- Pre-existing Deep Vein Thrombosis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Matteo Pavia
Pavia, PV, 27100
Michele Pagani, MD, 00390328502767, m.pagani@smatteo.pv.it
About this study
Official title: Prospective Study on the Incidence of Early Deep Vein Thrombosis After Peripherally Inserted Central Catheter Insertion
Deep Vein Thrombosis (DVT) is one of the most important complications after Peripherally Inserted Central Catheter (PICC) insertion. This study goals are to understand when and why DVT develops.
Read the detailed description
Deep Vein Thrombosis (DVT) is one of the most important complications after Peripherally Inserted Central Catheter (PICC) insertion. This study goals are to understand when and why DVT develops. Patients will be studied with ultrasound for 4 weeks after PICC insertion, one visit a week. The final outcome of PICCs will be collected.
- Conditions
- Venous Thrombosis
- Keywords
- Peripherally inserted central venous catheter
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PICC insertion | Peripherally Inserted Central Catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Deep Vein Thrombosis incidence assessed with weekly ultrasound examination
Measured: 4 weeks
Secondary outcomes (5)
Factors which may be correlated to Deep Vein Thrombosis development: obesity (Body Mass Index)
Body Mass Index (kg/m^2)
Measured: 4 weeks
Factors which may be correlated to Deep Vein Thrombosis development: cancer
Cancer yes/no
Measured: 4 weeks
Factors which may be correlated to Deep Vein Thrombosis development: previous Deep Vein Thrombosis
Previous Deep Vein Thrombosis yes/no
Measured: 4 weeks
Factors which may be correlated to Deep Vein Thrombosis development: Heparin-induced thrombocytopenia
Heparin-induced thrombocytopenia yes/no
Measured: 4 weeks
Overall Deep Vein Thrombosis incidence
Number of patients with Deep Vein Thrombosis/total number of patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
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 Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Pagani, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Michele Pagani, MD, Principal investigator, IRCCS Policlinico San Matteo Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752984
- Sponsor's protocol ID
- TROMBOSI VENOSA PROFONDA
- Acronym
- DVT-PICC
- Status last verified
- Apr 2016
- First submitted
- 11 Apr 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chopra V, Ratz D, Kuhn L, Lopus T, Lee A, Krein S. Peripherally inserted central catheter-related deep vein thrombosis: contemporary patterns and predictors. J Thromb Haemost. 2014 Jun;12(6):847-54. doi: 10.1111/jth.12549.
PubMed 24612469Zochios V, Umar I, Simpson N, Jones N. Peripherally inserted central catheter (PICC)-related thrombosis in critically ill patients. J Vasc Access. 2014 Sep-Oct;15(5):329-37. doi: 10.5301/jva.5000239. Epub 2014 Apr 25.
PubMed 24811591
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Incidence of Early Deep Vein Thrombosis After Peripherally Inserted Central Catheter Insertion
- ClinicalTrials.gov ID
- NCT02752984
- Acronym / sponsor ID
- DVT-PICC / TROMBOSI VENOSA PROFONDA
- Conditions
- Venous Thrombosis
- Keywords
- Peripherally inserted central venous catheter
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 27 Apr 2016 (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.
Deep Vein Thrombosis (DVT) is one of the most important complications after Peripherally Inserted Central Catheter (PICC) insertion. This study goals are to understand when and why DVT develops.
Detailed description
Deep Vein Thrombosis (DVT) is one of the most important complications after Peripherally Inserted Central Catheter (PICC) insertion. This study goals are to understand when and why DVT develops. Patients will be studied with ultrasound for 4 weeks after PICC insertion, one visit a week. The final outcome of PICCs will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PICC insertion | – | –Peripherally Inserted Central Catheter insertion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with Peripherally Inserted Central Catheter insertion
Key inclusion criteria (1 listed)
- Peripherally Inserted Central Catheter insertion
Key exclusion criteria (1 listed)
- Pre-existing Deep Vein Thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early Deep Vein Thrombosis incidence assessed with weekly ultrasound examination
Time frame: 4 weeks
5 secondary outcomes
Factors which may be correlated to Deep Vein Thrombosis development: obesity (Body Mass Index)
Time frame: 4 weeks
Factors which may be correlated to Deep Vein Thrombosis development: cancer
Time frame: 4 weeks
Factors which may be correlated to Deep Vein Thrombosis development: previous Deep Vein Thrombosis
Time frame: 4 weeks
Factors which may be correlated to Deep Vein Thrombosis development: Heparin-induced thrombocytopenia
Time frame: 4 weeks
Overall Deep Vein Thrombosis incidence
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Background: PubMed 24612469Chopra V, Ratz D, Kuhn L, Lopus T, Lee A, Krein S. Peripherally inserted central catheter-related deep vein thrombosis: contemporary patterns and predictors. J Thromb Haemost. 2014 Jun;12(6):847-54. doi: 10.1111/jth.12549.
- Background: PubMed 24811591Zochios V, Umar I, Simpson N, Jones N. Peripherally inserted central catheter (PICC)-related thrombosis in critically ill patients. J Vasc Access. 2014 Sep-Oct;15(5):329-37. doi: 10.5301/jva.5000239. Epub 2014 Apr 25.
- 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.
Michele Pagani, MD principal investigator
IRCCS Policlinico San Matteo Pavia
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 Venous Thrombosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia 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 1 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: status not confirmed, as of the sponsor's last update on 27 Apr 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michele Pagani, MD (00390328502767, m.pagani@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Deep Vein Thrombosis incidence assessed with weekly ultrasound examination (time frame: 4 weeks). 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 NCT02752984, 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 27 Apr 2016.