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

Not Applicable

Terminated

• Conditions: Deep Vein Thrombosis
• Interventions: Device: Pneumatic SCD - VenaFlow System (DJO Global)

• Registration Number: NCT01670188
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-22
• Primary Completion: 2016-10-13
• Study Completion: 2016-10-13
• Status Verified: 2017-08
• Results First Submitted: 2017-12-12
• Results First Submitted QC: 2017-12-12
• Last Update Submitted: 2017-12-12
• Results First Posted: 2018-01-09
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 78

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pneumatic SCD	Pneumatic SCD - VenaFlow System (DJO Global)	Use of pneumatic SCD (VenaFlow System - DJO Global) on upper extremity with PICC line inserted.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States