Quantra Determination of Coagulation Parameters in Arterial and Venous Blood

Cardiac Surgery Clinical Trial

Official title:

Comparison of Coagulation Parameters in Arterial and Venous Blood Measured Using the Quantra System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02978872
• Other study ID #: HEMCS-005
• Status: Completed
• Phase: N/A
• First received: November 28, 2016
• Last updated: April 18, 2017
• Start date: July 2016
• Est. completion date: January 2017

Study information

• Verified date: April 2017
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Quantra™ System is a novel point-of-care diagnostic device designed to perform whole blood coagulation analysis. This study compares Quantra measurements determined in arterial versus venous blood samples obtained from patients undergoing cardiac surgery.

Description:

The Quantra System is a fully integrated and automated in vitro diagnostic device which utilizes SEER Sonorheometry, an ultrasound-based technology, to characterize the dynamic changes in the viscoelastic properties of a blood sample during coagulation and clot lysis. Viscoelastic testing performed using existing technologies is typically performed on arterial samples obtained from patients undergoing surgical procedures, although reference ranges for these tests have been established for venous blood only.

The aim of this study is to evaluate potential differences between Quantra measurements determined in arterial versus venous blood samples obtained from patients undergoing cardiac surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device

• Subject is =18 years

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

• Subject may participate if they have a history of bleeding or are on preoperative anticoagulant therapy

Exclusion Criteria:

• Subject is unable to provide written informed consent

• Subject is younger than 18 years

• Subject is incarcerated at the time of the study

• Subject is currently enrolled in a study that may confound the results of the proposed study

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

Related Conditions & MeSH terms

• Cardiac Surgery

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
HemoSonics LLC	University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Clot Time and Clot Stiffness results between arterial and venous samples	Coagulation function assessed by Quantra at 2 time points (Baseline and either during cardiac bypass or post-bypass)	Up to 24 hours
Secondary	Comparison of Quantra results to standard coagulation test results in venous samples	Coagulation function assessed by Quantra and standard coagulation tests at 2 time points (Baseline and either during cardiac bypass or post-bypass)	Up to 24 hours
Secondary	Comparison of Quantra results to comparable ROTEM results in venous samples	Coagulation function assessed by Quantra and ROTEM at 2 time points (Baseline and either during cardiac bypass or post-bypass)	Up to 24 hours