An observational study in Central Venous Catheter Thrombosis, sponsored by University of Turin, Italy. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-11.
Sponsored by University of Turin, Italy · Observational
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
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.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's enrollment of 150 is below the median of 213 across 586 observational studies indexed under Thrombosis.
Browse Thrombosis studies →University of Turin, Italy is the lead sponsor of 206 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients undergoing a PICC-line positioning during a five-months period
Exclusion Criteria:
All patients carrying a peripherally inserted central catheter in our service
Other: PICC-carrying patients
Echographic monitoring of patients carrying a peripherally inserted central catheter
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
Time frame: 1 yr
risk factors individuation
Time frame: 1 yr
DVT resolution with early therapy
Time frame: 1yr
No study locations are listed for this record.
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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University of Turin, Italy