Hemosonics- VCU Cardiac Surgery Clinical Study

Cardiac Surgery Clinical Trial

Official title:

Hemosonics- VCU Cardiac Surgery Clinical Study Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02392247
• Other study ID #: FTU-002-007
• Status: Recruiting
• Phase: N/A
• First received: March 12, 2015
• Last updated: June 17, 2015
• Start date: April 2015

Study information

• Verified date: June 2015
• Source: Virginia Commonwealth University
• Contact: Emily Cochran, RN
• Phone: 804-628-4902
• Email: edcochran[@]vcu.edu
• 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 cardiac surgery 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 provide a preliminary evaluation of the performance comparability of the HemoSonics' device as compared to existing coagulation monitoring technology in heart surgery. This study will be performed at HemoSonics and the Virginia Commonwealth University Medical Center and will involve patients undergoing cardiac surgery requiring bypass.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Subject is scheduled for cardiac surgery involving bypass circuit

• 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

• Patients on emergency cases

Study Design

N/A

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Procedure:
• Blood specimen collection

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	HemoSonics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clot time	Coagulation Function	1 day	No
Primary	Clot Amplitude	Coagulation Function	1 day	No