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

Primary Purpose

Deep Vein Thrombosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pneumatic SCD - VenaFlow System (DJO Global)
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deep Vein Thrombosis focused on measuring Pneumatic sequential compression device (SCD), Peripherally Inserted Central Catheters (PICC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Pneumatic SCD

Non-SCD group

Arm Description

Use of pneumatic SCD (VenaFlow System - DJO Global) on upper extremity with PICC line inserted.

Standard care

Outcomes

Primary Outcome Measures

Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis
Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter

Secondary Outcome Measures

Full Information

First Posted
August 16, 2012
Last Updated
December 12, 2017
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01670188
Brief Title
SCD Use to Prevent Deep Venous Thrombosis (DVT) in Patients With PICC Lines
Official Title
Sequential Pneumatic Compression to Prevent PICC-related Upper Extremity Venous Thrombosis in Critically Ill Neurological Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis: patients treated with SCD had higher incidence of DVT.
Study Start Date
August 2012 (Actual)
Primary Completion Date
October 13, 2016 (Actual)
Study Completion Date
October 13, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis
Keywords
Pneumatic sequential compression device (SCD), Peripherally Inserted Central Catheters (PICC)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pneumatic SCD
Arm Type
Active Comparator
Arm Description
Use of pneumatic SCD (VenaFlow System - DJO Global) on upper extremity with PICC line inserted.
Arm Title
Non-SCD group
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Device
Intervention Name(s)
Pneumatic SCD - VenaFlow System (DJO Global)
Other Intervention Name(s)
VenaFlow System (DJO Global)
Primary Outcome Measure Information:
Title
Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Rabinstein, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31236782
Citation
Rabinstein AA, Hellickson JD, Macedo TA, Lewis BD, Mandrekar J, McBane RD 2nd. Sequential Pneumatic Compression in the Arm in Neurocritical Patients with a Peripherally Inserted Central Venous Catheter: A Randomized Trial. Neurocrit Care. 2020 Feb;32(1):187-192. doi: 10.1007/s12028-019-00765-w.
Results Reference
derived

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

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