Sequential Pneumatic Compression to Prevent PICC-related Upper Extremity Venous Thrombosis in Critically Ill Neurological Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Mayo Clinic
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Pneumatic SCD
Use of pneumatic SCD (VenaFlow System - DJO Global) on upper extremity with PICC line inserted.
Intervention: Pneumatic SCD - VenaFlow System (DJO Global) (Device)
Non-SCD group
Standard care
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Alejandro Rabinstein
PI
Mayo Clinic