Deep Vein Thrombosis
Conditions
Keywords
Pneumatic sequential compression device (SCD), Peripherally Inserted Central Catheters (PICC)
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPneumatic SCD - VenaFlow System (DJO Global)
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis | baseline to 14 days post insertion of PICC line | Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter |
Countries
United States
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| Pneumatic SCD Use of pneumatic sequential compression device (SCD) (VenaFlow System - DJO Global) on upper extremity with peripherally inserted central catheter (PICC) line inserted. | 38 |
| Non-SCD Group Patients enrolled in this group received standard care. | 39 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
Baseline characteristics
| Characteristic | Non-SCD Group | Total | Pneumatic SCD |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 21 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 56 Participants | 27 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 39 participants | 77 participants | 38 participants |
| Sex: Female, Male Female | 26 Participants | 49 Participants | 23 Participants |
| Sex: Female, Male Male | 13 Participants | 28 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 39 |
| other Total, other adverse events | 0 / 38 | 0 / 39 |
| serious Total, serious adverse events | 0 / 38 | 0 / 39 |
Outcome results
Primary
Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis
Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter
Time frame: baseline to 14 days post insertion of PICC line
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pneumatic SCD | Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis | 13 Participants |
| Non-SCD Group | Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis | 5 Participants |
p-value: 0.02t-test, 2 sided