Study on the Incidence of Early Deep Vein Thrombosis After Peripherally Inserted Central Catheter Insertion (DVT-PICC)

April 26, 2016 updated by: Michele Pagani, IRCCS Policlinico S. Matteo

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PV
      • Pavia, PV, Italy, 27100
        • Recruiting
        • IRCCS Policlinico San Matteo Pavia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

People with Peripherally Inserted Central Catheter insertion

Description

Inclusion Criteria:

  • Peripherally Inserted Central Catheter insertion

Exclusion Criteria:

  • Pre-existing Deep Vein Thrombosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PICC insertion
Peripherally Inserted Central Catheter insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Early Deep Vein Thrombosis incidence assessed with weekly ultrasound examination
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors which may be correlated to Deep Vein Thrombosis development: obesity (Body Mass Index)
Time Frame: 4 weeks
Body Mass Index (kg/m^2)
4 weeks
Factors which may be correlated to Deep Vein Thrombosis development: cancer
Time Frame: 4 weeks
Cancer yes/no
4 weeks
Factors which may be correlated to Deep Vein Thrombosis development: previous Deep Vein Thrombosis
Time Frame: 4 weeks
Previous Deep Vein Thrombosis yes/no
4 weeks
Factors which may be correlated to Deep Vein Thrombosis development: Heparin-induced thrombocytopenia
Time Frame: 4 weeks
Heparin-induced thrombocytopenia yes/no
4 weeks
Overall Deep Vein Thrombosis incidence
Time Frame: 6 months
Number of patients with Deep Vein Thrombosis/total number of patients
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Matteo

Investigators

  • Principal Investigator: Michele Pagani, MD, IRCCS Policlinico San Matteo Pavia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

April 11, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TROMBOSI VENOSA PROFONDA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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