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Radial, Sequential Compression Device Deep Venous Thrombosis Detection Study

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ClinicalTrials.gov Identifier: NCT04232501
Recruitment Status : Withdrawn (Due to COVID-19, Radial slowed their operations. Hence the investigational device is not available.)
First Posted : January 18, 2020
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Adam Schlifke, Stanford University

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.

Condition or disease Intervention/treatment Phase
Deep Venous Thrombosis Device: Cirvo Compression device Not Applicable

Detailed Description:
Compression therapy of the leg is a proven and well-established modality to prevent deep vein thrombosis in immobilized and post-surgical patients. The investigators aim to compare a new sequential compression for the leg that utilizes a servo motor for compression as opposed to a traditional pneumatic motor that is typically used in the hospital and after surgery. Pneumatic sequential compression devices are cumbersome, expensive and not mobile. This new compression device was developed to provide a cheaper, mobile device that can be worn by the patient after surgery and while at home during ambulation. The addition of the servo motor and fine sensors may also be able to detect sub-clinical DVT's that contribute to post-surgical pulmonary embolus and post-surgical complications. The investigators aim to learn how this new device performs in the subset of patients undergoing complex spine surgery, the incidence of post-surgical DVT with this new device compared to traditional SCD and if this new device is capable of detecting sub-clinical post-surgical DVT.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effect of Novel Sequential Compression Device on the Incidence of Deep Venous Thrombosis on Complex Surgical Spine Patients
Actual Study Start Date : January 8, 2021
Estimated Primary Completion Date : January 8, 2021
Estimated Study Completion Date : January 8, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cirvo Compression device post surgery
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.
Device: Cirvo Compression device
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.

No Intervention: Standard of Care Post Surgery
Patients receive standard-issue SCDs (pneumatic compression) and wear in surgery and after surgery until they are discharged home.



Primary Outcome Measures :
  1. Incidence of Deep Vein Thrombosis (DVT) [ Time Frame: Within four weeks after surgery ]
    Number of participants with DVT diagnosed by ultrasound after complex spine surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for complex spine surgery at Stanford Hospital

Exclusion Criteria:

  • Pregnancy
  • Non-decisional capacity
  • Incarcerated persons
  • Any hereditary or acquired coagulopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04232501


Locations
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United States, California
Stanford Hospital and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Adam Schlifke Stanford University
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Responsible Party: Adam Schlifke, Clinical Assistant Professor, Anesthesia, Stanford University
ClinicalTrials.gov Identifier: NCT04232501    
Other Study ID Numbers: IRB-54247
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases