Study Stopped
Interim analysis: patients treated with SCD had higher incidence of DVT.
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
1 other identifier
interventional
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 16, 2012
CompletedFirst Posted
Study publicly available on registry
August 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2016
CompletedResults Posted
Study results publicly available
January 9, 2018
CompletedJanuary 9, 2018
August 1, 2017
4.2 years
August 16, 2012
December 12, 2017
December 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis
Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter
baseline to 14 days post insertion of PICC line
Study Arms (2)
Pneumatic SCD
ACTIVE COMPARATORUse of pneumatic SCD (VenaFlow System - DJO Global) on upper extremity with PICC line inserted.
Non-SCD group
NO INTERVENTIONStandard care
Interventions
Eligibility Criteria
You may qualify if:
- Subject's age is greater than or equal to 18 years
- Subject is patient in neuro intensive care unit at time of PICC placement
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Publications (1)
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.
PMID: 31236782DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated early because the pre-determined interim analysis showed patients treated with the SCD had higher incidence of DVT by ultrasound.
Results Point of Contact
- Title
- Dr. Alejandro Rabinstein
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Alejandro Rabinstein, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
August 16, 2012
First Posted
August 22, 2012
Study Start
August 1, 2012
Primary Completion
October 13, 2016
Study Completion
October 13, 2016
Last Updated
January 9, 2018
Results First Posted
January 9, 2018
Record last verified: 2017-08