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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cristina Garrino, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT01779999
First received: January 28, 2013
Last updated: February 8, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Central Venous Catheter Thrombosis
 Other: PICC-carrying patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study With Ultrasonographic Screening for Early Detection of PICC-related DVT, Results of Early Beginning of Anticoagulant Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • early detection of PRDVT [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • risk factors individuation [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • DVT resolution with early therapy [ Time Frame: 1yr ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: June 2010
Study Completion Date: June 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779999

Sponsors and Collaborators
University of Turin, Italy
Investigators
Principal Investigator: cristina garrino, PhD University of Turin
  More Information

No publications provided

Responsible Party: Cristina Garrino, PhD, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01779999     History of Changes
Other Study ID Numbers: SGB0012226
Study First Received: January 28, 2013
Last Updated: February 8, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Turin, Italy:
central venous catheters
thrombosis
secondary prevention

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Upper Extremity Deep Vein Thrombosis
 Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013