HemoSonics-UVA Spinal Surgery

Deformity of Spine Clinical Trial

Official title:

HemoSonics-UVA Spinal Surgery Clinical Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418923
• Other study ID #: 17942
• Status: Completed
• Phase: N/A
• First received: April 13, 2015
• Last updated: May 10, 2016
• Start date: April 2015
• Est. completion date: August 2015

Study information

• Verified date: May 2016
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in neurosurgery patients.

Description:

HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia.

Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.

A clinical study will be conducted to evaluate the analytical performance as well as compared to existing coagulation monitoring technology

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • Subject is scheduled for major deformity correction spine surgery

• Subject is older than 18 years

• Subject is willing to participate and he/she has signed a consent form

Exclusion Criteria:

• • Subject is unable to provide written informed consent

• Subject is incarcerated at the time of the study

• Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks

• Subjects with renal disease (defined as serum creatinine greater than 1.5 mg/dl)

• Subjects with history of active liver disease

• Subjects affected by Factor V Leiden mutation

• Subjects affected by von Willebrand disease

• Subjects with an history of thrombotic disease (more than one DVT)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deformity of Spine

Intervention

Other:
• Procedure: Blood specimen collection
Blood specimen collection

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	HemoSonics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assay inter-instrument variability	Demonstrate assay inter-instrument variability below 15%	1 day	No
Primary	Establish normal ranges	Establish normal ranges	1 day	No