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Clinical Trials/NCT01670188
NCT01670188
Terminated
Not Applicable

Sequential Pneumatic Compression to Prevent PICC-related Upper Extremity Venous Thrombosis in Critically Ill Neurological Patients

Mayo Clinic1 site in 1 country78 target enrollmentAugust 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deep Vein Thrombosis
Sponsor
Mayo Clinic
Enrollment
78
Locations
1
Primary Endpoint
Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis
Status
Terminated
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to see if a compression device on the arm where a peripherally inserted central catheter (PICC) line has been inserted can prevent the formation of a blood clot around the PICC line.

Detailed Description

In a pilot prospective randomized controlled trial, consecutive patients requiring placement of a PICC line in the Neuroscience intensive care unit were randomly assigned to either the SCD (intervention) group or a non SCD (control) group. Standardized vascular access patency protocols was used in all enrolled patients. All patients had an indwelling 5 French, double lumen PICC unless additional venous access was required by the primary service. Patients randomized to the intervention arm had an SCD placed in the arm with the PICC within 24 hours of PICC placement. Five to seven days after placement of the PICC, the patients were examined with venous duplex ultrasound of the upper extremity to assess for the presence of venous thrombosis. The patients also had the ultrasound again 12-14 days post insertion if the PICC was kept for more than 10 days. If the PICC line was removed before 5-7 days, an upper extremity ultrasound was obtained upon PICC removal. In case of suspected symptomatic venous thromboembolism, the investigations were performed according to current practice standards. Data collection was be considered complete upon removal of the PICC line.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
October 13, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alejandro Rabinstein

PI

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Subject's age is greater than or equal to 18 years
  • Subject is patient in neuro intensive care unit at time of PICC placement

Exclusion Criteria

  • Acute trauma to the upper extremity harboring the PICC
  • Current use of prophylactic anticoagulation
  • Inability to fit the SCD on the arm because of arm size
  • Documented previous upper extremity DVT in the arm harboring the PICC line

Outcomes

Primary Outcomes

Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis

Time Frame: baseline to 14 days post insertion of PICC line

Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter

Study Sites (1)

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