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SCD Use to Prevent DVT in Patients With PICC Lines

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Alejandro Rabinstein, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01670188
First received: August 16, 2012
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Rate of ultrasonographically-confirmed venous thrombosis [ Time Frame: baseline to 14 days post insertion of PICC line ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: November 2013
Estimated Primary Completion Date: November 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alejandro Rabinstein, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01670188     History of Changes
Other Study ID Numbers: 12-004676
Study First Received: August 16, 2012
Last Updated: May 10, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013