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NCT02752984 Clinical Trial

Study on the Incidence of Early Deep Vein Thrombosis After Peripherally Inserted Central Catheter Insertion

Venous Thrombosis Clinical Trial

— DVT-PICC  

Official title:
Prospective Study on the Incidence of Early Deep Vein Thrombosis After Peripherally Inserted Central Catheter Insertion

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02752984
Other study ID # TROMBOSI VENOSA PROFONDA
Secondary ID
Status Recruiting
Phase N/A
First received April 11, 2016
Last updated April 26, 2016
Start date April 2016
Est. completion date June 2018

Study information
Verified date April 2016
Source IRCCS Policlinico S. Matteo
Contact Michele Pagani, MD
Phone 00390328502767
Email m.pagani@smatteo.pv.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date June 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Peripherally Inserted Central Catheter insertion

Exclusion Criteria:

- Pre-existing Deep Vein Thrombosis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Italy IRCCS Policlinico San Matteo Pavia Pavia PV

Sponsors (1)
Lead Sponsor Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

Zochios 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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Early Deep Vein Thrombosis incidence assessed with weekly ultrasound examination 4 weeks No
Secondary Factors which may be correlated to Deep Vein Thrombosis development: obesity (Body Mass Index) Body Mass Index (kg/m^2) 4 weeks No
Secondary Factors which may be correlated to Deep Vein Thrombosis development: cancer Cancer yes/no 4 weeks No
Secondary Factors which may be correlated to Deep Vein Thrombosis development: previous Deep Vein Thrombosis Previous Deep Vein Thrombosis yes/no 4 weeks No
Secondary Factors which may be correlated to Deep Vein Thrombosis development: Heparin-induced thrombocytopenia Heparin-induced thrombocytopenia yes/no 4 weeks No
Secondary Overall Deep Vein Thrombosis incidence Number of patients with Deep Vein Thrombosis/total number of patients 6 months No
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