SCD Use to Prevent Deep Venous Thrombosis (DVT) in Patients With PICC Lines

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Deep Vein Thrombosis

Intervention / Treatment
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* Device: Pneumatic SCD - VenaFlow System (DJO Global)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pneumatic SCD<br>Use of pneumatic SCD (VenaFlow System - DJO Global) on upper extremity with PICC line inserted. | Device: Pneumatic SCD - VenaFlow System (DJO Global)<br> <br> * Other names: VenaFlow System (DJO Global);|
| No Intervention: Non-SCD group<br>Standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis | Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter | baseline to 14 days post insertion of PICC line | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumatic sequential compression device (SCD), Peripherally Inserted Central Catheters (PICC)