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

Deep Vein Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01670188
• Other study ID #: 12-004676
• Status: Terminated
• Phase: N/A
• First received: August 16, 2012
• Last updated: December 12, 2017
• Start date: August 2012
• Est. completion date: October 13, 2016

Study information

• Verified date: August 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: October 13, 2016
• Est. primary completion date: October 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• Pneumatic SCD - VenaFlow System (DJO Global)

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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