Effect of Novel Sequential Compression Device on the Incidence of Deep Venous Thrombosis on Complex Surgical Spine Patients
| Registry | NCT04232501 |
|---|---|
| Status | Withdrawn - Due to COVID-19, Radial slowed their operations. Hence the investigational device is not available. |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, prevention |
| Sponsor | Stanford University (Other) |
| Conditions | Deep Venous Thrombosis |
| Interventions | Cirvo Compression device (Device) |
| Dates | start 2021-01-08, primary completion 2021-01-08 (estimated), completion 2021-01-08 (estimated), first posted 2020-01-18, last updated 2021-01-12 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Deep Venous Thrombosis All trials of Cirvo Compression device
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cirvo Compression device post surgery | Experimental | 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. |
| Standard of Care Post Surgery | No intervention | Patients receive standard-issue SCDs (pneumatic compression) and wear in surgery and after surgery until they are discharged home. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Patients scheduled for complex spine surgery at Stanford Hospital Exclusion Criteria: * Pregnancy * Non-decisional capacity * Incarcerated persons * Any hereditary or acquired coagulopathy
| Facility | City | Country | Status |
|---|---|---|---|
| Stanford Hospital and Clinics | Stanford, California | United States |