Trial Outcomes & Findings for SCD Use to Prevent Deep Venous Thrombosis (DVT) in Patients With PICC Lines (NCT NCT01670188)
NCT ID: NCT01670188
Last Updated: 2018-01-09
Results Overview
Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter
TERMINATED
NA
78 participants
baseline to 14 days post insertion of PICC line
2018-01-09
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
40
|
|
Overall Study
COMPLETED
|
38
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pneumatic SCD
n=38 Participants
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
n=39 Participants
Patients enrolled in this group received standard care.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=38 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=77 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=38 Participants
|
29 Participants
n=39 Participants
|
56 Participants
n=77 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=38 Participants
|
10 Participants
n=39 Participants
|
21 Participants
n=77 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=38 Participants
|
26 Participants
n=39 Participants
|
49 Participants
n=77 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=38 Participants
|
13 Participants
n=39 Participants
|
28 Participants
n=77 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
38 participants
n=38 Participants
|
39 participants
n=39 Participants
|
77 participants
n=77 Participants
|
PRIMARY outcome
Timeframe: baseline to 14 days post insertion of PICC lineUltrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter
Outcome measures
| Measure |
Pneumatic SCD
n=38 Participants
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
n=39 Participants
Patients enrolled in this group received standard care.
|
|---|---|---|
|
Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis
|
13 Participants
|
5 Participants
|
Adverse Events
Pneumatic SCD
Non-SCD Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place