Early Detection of PICC-related Deep Vein Thrombosis by US Surveillance: an Effective Approach for Secondary Prevention?

NCT01779999 | Completed

• 1 other identifier: SGB0012226
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: PICC-related thrombosis have shown a slightly different pattern of frequency and risk factors, compared with traditional CVC; because of the increasing diffusion of PICCs, they are becoming a somehow independent pathology, still under investigation; no pharmacological prevention has proved to be effective. Aim of this study is to estimate the cumulative incidence of thrombosis in a cohort of patients carrying a PICC-line CVC, monitored to allow an early detection and prevention of complications related to the presence of asymptomatic deep venous thrombosis, and to explore the role of several potential risk factors. Methods: in a prospective observational cohort we will enroll 150 consecutive patients having a PICC inserted by our team; clinical characteristics, comorbidities and main features of catheter positioning procedure will be registered; patients will be followed with clinical and echographic scheduled controls, weekly for the first month, then monthly; patients with PRDVT will be treated with LMWH and recontrolled weekly until removal of catheter

Conditions

Central Venous Catheter Thrombosis

Keywords

central venous catheters; thrombosis; secondary prevention

Outcome Measures

Primary Outcomes (1)

• early detection of PRDVT

  weekly ultrasonographic examination of the whole upper limbs venous district, axillary, subclavian and jugular veins for detecting incompressibility of the vein or visualization of thrombus; Doppler examination for confirmation of DVT

  1 yr

Secondary Outcomes (1)

• risk factors individuation

  1 yr

Other Outcomes (1)

• DVT resolution with early therapy

  1yr

Study Arms (1)

PICC-carrying patients

All patients carrying a peripherally inserted central catheter in our service

Other: PICC-carrying patients

Interventions

PICC-carrying patients OTHER

Echographic monitoring of patients carrying a peripherally inserted central catheter

PICC-carrying patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing a PICC-line positioning during a five-months period

You may qualify if:

• all patients undergoing a PICC-line positioning during a five-months period

You may not qualify if:

• age\<18,complete paresis of the arm, history of previous DVT in the same arm, expected very short PICC indwelling time (less than 1 week).

Sponsors & Collaborators

• University of Turin, Italy: lead

MeSH Terms

Conditions

Upper Extremity Deep Vein Thrombosis; Thrombosis

Condition Hierarchy (Ancestors)

Venous Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• cristina garrino, PhD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: January 30, 2013
• Study Start: June 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: June 1, 2012
• Last Updated: February 11, 2013

Record last verified: 2013-01