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

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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):
Alejandro Rabinstein, Mayo Clinic

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Deep Vein Thrombosis
Intervention: Device: Pneumatic SCD - VenaFlow System (DJO Global)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients requiring placement of a peripherally inserted central catheter (PICC) line in the neuroscience intensive care unit were recruited at Mayo Clinic in Rochester, Minnesota.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient randomized to the non-SCD arm died before the first ultrasound could be obtained and therefore could not be entered into the analysis.

Reporting Groups
  Description
Pneumatic SCD Use of pneumatic sequential compression device (SCD) (VenaFlow System - DJO Global) on upper extremity with peripherally inserted central catheter (PICC) line inserted.
Non-SCD Group Patients enrolled in this group received standard care.

Participant Flow:   Overall Study
    Pneumatic SCD   Non-SCD Group
STARTED   38   40 
COMPLETED   38   39 
NOT COMPLETED   0   1 
Death                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pneumatic SCD Use of pneumatic sequential compression device (SCD) (VenaFlow System - DJO Global) on upper extremity with peripherally inserted central catheter (PICC) line inserted.
Non-SCD Group Patients enrolled in this group received standard care.
Total Total of all reporting groups

Baseline Measures
   Pneumatic SCD   Non-SCD Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   39   77 
Age 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 38   39   77 
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      27  71.1%      29  74.4%      56  72.7% 
>=65 years      11  28.9%      10  25.6%      21  27.3% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 38   39   77 
Female      23  60.5%      26  66.7%      49  63.6% 
Male      15  39.5%      13  33.3%      28  36.4% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 0   0   0 
         0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed 
[Units: Participants]
 38   39   77 
United States   38   39   77 


  Outcome Measures

1.  Primary:   Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis   [ Time Frame: baseline to 14 days post insertion of PICC line ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated early because the pre-determined interim analysis showed patients treated with the SCD had higher incidence of DVT by ultrasound.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Alejandro Rabinstein
Organization: Mayo Clinic
phone: 507-284-4741
e-mail: Rabinstein.Alejandro@mayo.edu



Responsible Party: Alejandro Rabinstein, 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
Results First Submitted: December 12, 2017
Results First Posted: January 9, 2018
Last Update Posted: January 9, 2018