Study Stopped
Due to COVID-19, Radial slowed their operations. Hence the investigational device is not available.
Radial, Sequential Compression Device Deep Venous Thrombosis Detection Study
Effect of Novel Sequential Compression Device on the Incidence of Deep Venous Thrombosis on Complex Surgical Spine Patients
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to evaluate the effectiveness of a new leg compression device in preventing post-surgical deep vein thrombosis (blood clot) that can occur after major and complex spine surgery. The investigators aim to show that this new compression device is no worse than the standard sequential compression device (SCD) at preventing DVT and may be able to detect deep vein thrombosis in patients who are not typically screened for this diagnosis after surgery. This new device may be able to capture an important post-surgical complication while providing a more comfortable treatment option.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
January 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2021
CompletedJanuary 12, 2021
January 1, 2021
Same day
January 14, 2020
January 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Deep Vein Thrombosis (DVT)
Number of participants with DVT diagnosed by ultrasound after complex spine surgery
Within four weeks after surgery
Study Arms (2)
Cirvo Compression device post surgery
EXPERIMENTALPatients will wear Cirvo compression device during the surgery, after surgery and will be discharged to home with the device to wear at home as the per study protocol instructions.
Standard of Care Post Surgery
NO INTERVENTIONPatients receive standard-issue SCDs (pneumatic compression) and wear in surgery and after surgery until they are discharged home.
Interventions
Patients will wear Cirvo compression device during the surgery, after surgery and will be discharged to home with the device to wear at home as the per study protocol instructions.
Eligibility Criteria
You may qualify if:
- Patients scheduled for complex spine surgery at Stanford Hospital
You may not qualify if:
- Pregnancy
- Non-decisional capacity
- Incarcerated persons
- Any hereditary or acquired coagulopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford Hospital and Clinics
Stanford, California, 94305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Schlifke
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor, Anesthesia
Study Record Dates
First Submitted
January 14, 2020
First Posted
January 18, 2020
Study Start
January 8, 2021
Primary Completion
January 8, 2021
Study Completion
January 8, 2021
Last Updated
January 12, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share