Radial, Sequential Compression Device Deep Venous Thrombosis Detection Study

Not Applicable

Withdrawn

• Conditions: Deep Venous Thrombosis
• Interventions: Device: Cirvo Compression device

• Registration Number: NCT04232501
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-14
• Study First Posted: 2020-01-18
• Status Verified: 2021-01
• Study Start: 2021-01-08
• Primary Completion: 2021-01-08
• Study Completion: 2021-01-08
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients scheduled for complex spine surgery at Stanford Hospital

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cirvo Compression device post surgery	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Deep Vein Thrombosis (DVT)	Within four weeks after surgery	Number of participants with DVT diagnosed by ultrasound after complex spine surgery

Trial Locations

Locations (1)

Stanford Hospital and Clinics; 🇺🇸 Stanford, California, United States