Radial, Sequential Compression Device Deep Venous Thrombosis Detection Study

Sponsor

Stanford University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04232501

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Jan 8, 2021

Anticipated Primary Completion Date :

Jan 8, 2021

Anticipated Study Completion Date :

Jan 8, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients scheduled for complex spine surgery at Stanford Hospital

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Hospital and Clinics	Stanford	California	United States	94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Adam Schlifke, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adam Schlifke, Clinical Assistant Professor, Anesthesia, Stanford University

ClinicalTrials.gov Identifier:

NCT04232501

Other Study ID Numbers:

IRB-54247

First Posted:

Jan 18, 2020

Last Update Posted:

Jan 12, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Thrombosis

Venous Thrombosis

Study Results

No Results Posted as of Jan 12, 2021