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SCD Use to Prevent Deep Venous Thrombosis (DVT) in Patients With PICC Lines

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.
ClinicalTrials.gov Identifier: NCT01670188
Recruitment Status : Terminated (Interim analysis: patients treated with SCD had higher incidence of DVT.)
First Posted : August 22, 2012
Results First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):

August 16, 2012
August 22, 2012
December 12, 2017
January 9, 2018
January 9, 2018
August 2012
October 13, 2016   (Final data collection date for primary outcome measure)
Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis [ Time Frame: baseline to 14 days post insertion of PICC line ]
Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter
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
Complete list of historical versions of study NCT01670188 on ClinicalTrials.gov Archive Site
Not Provided
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
Not Provided
Not Provided
 
SCD Use to Prevent Deep Venous Thrombosis (DVT) in Patients With PICC Lines
Sequential Pneumatic Compression to Prevent PICC-related Upper Extremity Venous Thrombosis in Critically Ill Neurological Patients
The purpose of this study is to see if a compression device on the arm where a peripherally inserted central catheter (PICC) line has been inserted can prevent the formation of a blood clot around the PICC line.

In a pilot prospective randomized controlled trial, consecutive patients requiring placement of a PICC line in the Neuroscience intensive care unit were randomly assigned to either the SCD (intervention) group or a non SCD (control) group.

Standardized vascular access patency protocols was used in all enrolled patients. All patients had an indwelling 5 French, double lumen PICC unless additional venous access was required by the primary service. Patients randomized to the intervention arm had an SCD placed in the arm with the PICC within 24 hours of PICC placement.

Five to seven days after placement of the PICC, the patients were examined with venous duplex ultrasound of the upper extremity to assess for the presence of venous thrombosis. The patients also had the ultrasound again 12-14 days post insertion if the PICC was kept for more than 10 days. If the PICC line was removed before 5-7 days, an upper extremity ultrasound was obtained upon PICC removal. In case of suspected symptomatic venous thromboembolism, the investigations were performed according to current practice standards. Data collection was be considered complete upon removal of the PICC line.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Deep Vein Thrombosis
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
78
October 13, 2016
October 13, 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)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01670188
12-004676
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Not Provided
Alejandro Rabinstein, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Alejandro Rabinstein, MD Mayo Clinic
Mayo Clinic
August 2017

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