Radial, Sequential Compression Device Deep Venous Thrombosis Detection Study

NCT ID: NCT04232501

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-08
• Study Completion Date: 2021-01-08

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.

Conditions

Deep Venous Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cirvo Compression device

Intervention Type: 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.

Standard of Care Post Surgery

Patients receive standard-issue SCDs (pneumatic compression) and wear in surgery and after surgery until they are discharged home.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Adam Schlifke

Clinical Assistant Professor, Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam Schlifke

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Hospital and Clinics

Stanford, California, United States

Countries

United States

Other Identifiers

IRB-54247

Identifier Type: -

Identifier Source: org_study_id