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 30, 2014
Last verified: May 2014

August 16, 2012
May 30, 2014
August 2012
July 2014   (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 ] [ Designated as safety issue: No ]
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 ] [ 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
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
102
July 2014
July 2014   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01670188
12-004676
No
Alejandro Rabinstein, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Alejandro Rabinstein, MD Mayo Clinic
Mayo Clinic
May 2014

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