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SCD Use to Prevent DVT in Patients With PICC Lines

This study is enrolling participants by invitation only.
ClinicalTrials.gov Identifier:
First Posted: August 22, 2012
Last Update Posted: April 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alejandro Rabinstein, Mayo Clinic
August 16, 2012
August 22, 2012
April 25, 2016
August 2012
December 2016   (Final data collection date for primary outcome measure)
Rate of ultrasonographically-confirmed venous thrombosis [ Time Frame: baseline to 14 days post insertion of PICC line ]
Rate of occurence of ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter
Same as current
Complete list of historical versions of study NCT01670188 on ClinicalTrials.gov Archive Site
Overall rate of symptomatic venous thromboembolism [ Time Frame: baseline to 14 days post insertion of PICC catheter ]
Overall rate of symptomatic venous thromboembolism (DVT, PE), rate of symptomatic or asymptomatic PICC-related DVT of upper extremity, PICC related superficial venous thrombosis of upper extremity, other complications related to PICC, and adverse effects attributable to use of SCD in the arm
Same as current
Not Provided
Not Provided
SCD Use to Prevent DVT in Patients With PICC Lines
Sequential Pneumatic Compression to Prevent PICC-related Upper Extremity Venous Thrombosis in Critically Ill Neurological Patients
Determine if the use of sequential pneumatic compression in the arm can prevent the formation of venous clots related to the presence of a peripherally inserted central catheter (PICC).
Not Provided
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Pneumatic Sequential Compression Device (SCD)
  • Peripherally Inserted Central Catheters (PICC)
Device: Pneumatic SCD - VenaFlow System (DJO Global)
Other Name: VenaFlow System (DJO Global)
  • Active Comparator: Pneumatic SCD
    Use of pneumatic SCD (VenaFlow System - DJO Global) on upper extremity with PICC line inserted
    Intervention: Device: Pneumatic SCD - VenaFlow System (DJO Global)
  • No Intervention: non-SCD group
    standard care with no pneumatic SCD not worn on arm with PICC catheter placement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Enrolling by invitation
December 2016
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Alejandro Rabinstein, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Alejandro Rabinstein, MD Mayo Clinic
Mayo Clinic
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP