Quantra Determination of Coagulation Parameters in Arterial and Venous Blood

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02978872

Enrollment

Registered

2016-12-01

Start date

2016-07-31

Completion date

2017-01-31

Last updated

2017-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Keywords

Cardiac surgery, Quantra, Viscoelastic testing, Coagulation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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)

Countries

United States

Outcome results