Quantra Determination of Coagulation Parameters in Arterial and Venous Blood

Completed

• Conditions: Cardiac Surgery

• Registration Number: NCT02978872
• Lead Sponsor: HemoSonics LLC

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-12-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of Clot Time and Clot Stiffness results between arterial and venous samples	Up to 24 hours	Coagulation function assessed by Quantra at 2 time points (Baseline and either during cardiac bypass or post-bypass)

Secondary Outcome Measures

Name	Time	Method
Comparison of Quantra results to comparable ROTEM results in venous samples	Up to 24 hours	Coagulation function assessed by Quantra and ROTEM at 2 time points (Baseline and either during cardiac bypass or post-bypass)
Comparison of Quantra results to standard coagulation test results in venous samples	Up to 24 hours	Coagulation function assessed by Quantra and standard coagulation tests at 2 time points (Baseline and either during cardiac bypass or post-bypass)

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States