NCT01670188

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Deep Vein Thrombosis

Interventions

Type	Name	Description
DEVICE	Pneumatic SCD - VenaFlow System (DJO Global)

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-10-13
• Completion: 2016-10-13
• First posted: 2012-08-22
• Last updated: 2018-01-09
• Results posted: 2018-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study