SCD Use to Prevent Deep Venous Thrombosis (DVT) in Patients With PICC Lines
|ClinicalTrials.gov Identifier: NCT01670188|
Recruitment Status : Terminated (Interim analysis: patients treated with SCD had higher incidence of DVT.)
First Posted : August 22, 2012
Results First Posted : January 9, 2018
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Deep Vein Thrombosis||Device: Pneumatic SCD - VenaFlow System (DJO Global)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sequential Pneumatic Compression to Prevent PICC-related Upper Extremity Venous Thrombosis in Critically Ill Neurological Patients|
|Actual Study Start Date :||August 2012|
|Actual Primary Completion Date :||October 13, 2016|
|Actual Study Completion Date :||October 13, 2016|
Active Comparator: Pneumatic SCD
Use of pneumatic SCD (VenaFlow System - DJO Global) on upper extremity with PICC line inserted.
Device: Pneumatic SCD - VenaFlow System (DJO Global)
Other Name: VenaFlow System (DJO Global)
No Intervention: Non-SCD group
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670188
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Alejandro Rabinstein, MD||Mayo Clinic|