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

Observational Study With Ultrasonographic Screening for Early Detection of PICC-related DVT, Results of Early Beginning of Anticoagulant Treatment

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

Study Overview

• Status: Completed
• Conditions: Central Venous Catheter Thrombosis
• Intervention / Treatment: Other: PICC-carrying patients

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PICC-carrying patients; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
risk factors individuation	1 yr

Other Outcome Measures

Outcome Measure	Time Frame
DVT resolution with early therapy	1yr

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Investigators: Principal Investigator: cristina garrino, PhD, University of Turin, Italy

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: January 28, 2013
• First Submitted That Met QC Criteria: January 28, 2013
• First Posted (Estimate): January 30, 2013

Study Record Updates

• Last Update Posted (Estimate): February 11, 2013
• Last Update Submitted That Met QC Criteria: February 8, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: secondary prevention; thrombosis; central venous catheters
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Upper Extremity Deep Vein Thrombosis
• Other Study ID Numbers: SGB0012226