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SCD Use to Prevent DVT in Patients With PICC Lines

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01670188
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
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670188


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

Responsible Party: Alejandro Rabinstein, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01670188     History of Changes
Other Study ID Numbers: 12-004676
First Submitted: August 16, 2012
First Posted: August 22, 2012
Last Update Posted: April 25, 2016
Last Verified: April 2016

Keywords provided by Alejandro Rabinstein, Mayo Clinic:
Pneumatic sequential compression device (SCD)
Peripherally Inserted Central Catheters (PICC)