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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01779999
Other study ID # SGB0012226
Secondary ID
Status Completed
Phase N/A
First received January 28, 2013
Last updated February 8, 2013
Start date June 2010
Est. completion date June 2012

Study information

Verified date January 2013
Source University of Turin, Italy
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial 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


Description:

All PICCs are positioned by trained physicians and nurses, after ultrasonographic screening of the whole upper limbs venous district, axillary, subclavian and jugular veins for detecting possible pre-existing thrombosis; positioning is performed with real-time ultrasonography guide with a portable device. Patients are recontrolled one week after positioning; patients who report pain, swelling, fever, skin colour changes, exit site tenderness, or any symptom suspected for thrombosis or infection, are immediately seen. A duplex ultrasound complete examination of the upper limb and neck vessels is performed, and at the same time the whole arm and the exit site is inspected to exclude infections; diagnostic criteria for DVT include incompressibility of the vein and direct visualisation of PICC-surrounding thrombus; in uncertain cases, a doppler examination is performed.If the examination is negative for thrombosis, further controls are performed at 2,3,4 weeks after positioning, then once a month.If a DVT is detected, we register the position and extension of the thrombus, and its main characteristics (clot, mural or occlusive thrombosis); the catheter is left in place and a therapy is prescribed with LMWH at full doses, according with ACCP guidelines 2008 (confirmed in 2012 edition). Then, the patient is recontrolled weekly until removal of the catheter.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date June 2012
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
PICC-carrying patients
Echographic monitoring of patients carrying a peripherally inserted central catheter

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Turin, Italy

Outcome

Type Measure Description Time frame Safety issue
Other DVT resolution with early therapy 1yr Yes
Primary 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 Yes
Secondary risk factors individuation 1 yr Yes
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