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SCD Use to Prevent DVT in Patients With PICC Lines

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Alejandro Rabinstein, Mayo Clinic Identifier:
First received: August 16, 2012
Last updated: April 22, 2016
Last verified: April 2016
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).

Condition Intervention
Pneumatic Sequential Compression Device (SCD) Peripherally Inserted Central Catheters (PICC) Device: Pneumatic SCD - VenaFlow System (DJO Global)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sequential Pneumatic Compression to Prevent PICC-related Upper Extremity Venous Thrombosis in Critically Ill Neurological Patients

Resource links provided by NLM:

Further study details as provided by Alejandro Rabinstein, Mayo Clinic:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 102
Study Start Date: August 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
standard care with no pneumatic SCD not worn on arm with PICC catheter placement


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01670188

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Alejandro Rabinstein, MD Mayo Clinic
  More Information

Responsible Party: Alejandro Rabinstein, PI, Mayo Clinic Identifier: NCT01670188     History of Changes
Other Study ID Numbers: 12-004676
Study First Received: August 16, 2012
Last Updated: April 22, 2016

Keywords provided by Alejandro Rabinstein, Mayo Clinic:
Pneumatic sequential compression device (SCD)
Peripherally Inserted Central Catheters (PICC) processed this record on September 19, 2017