Radial, Sequential Compression Device Deep Venous Thrombosis Detection Study

Deep Venous Thrombosis Clinical Trial

Official title:

Effect of Novel Sequential Compression Device on the Incidence of Deep Venous Thrombosis on Complex Surgical Spine Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04232501
• Other study ID #: IRB-54247
• Status: Withdrawn
• Phase: N/A
• Start date: January 8, 2021
• Est. completion date: January 8, 2021

Study information

• Verified date: January 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 8, 2021
• Est. primary completion date: January 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for complex spine surgery at Stanford Hospital

Exclusion Criteria:

• Pregnancy

• Non-decisional capacity

• Incarcerated persons

• Any hereditary or acquired coagulopathy

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford Hospital and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Deep Vein Thrombosis (DVT)	Number of participants with DVT diagnosed by ultrasound after complex spine surgery	Within four weeks after surgery