HemoSonics - UTMB Cardiac Surgery Study

HemoSonics

Status: Completed

Conditions: Blood Loss, Surgical

Treatments: Diagnostic Test: Quantra System

Study type: Observational

Funder types: Industry

Identifiers

NCT03988465

HEMCS-024

Details and patient eligibility

About

This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra QPlus Cartridge in patients undergoing cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.

Full description

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, and ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra QPlus Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system.

This single-center, prospective, observational study will evaluate the performance of the Quantra System as compared to and comparable measures determined using the TEG 5000.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is ≥ 18 years
• Subject is scheduled for cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.
• Subject is willing to participate, and he/she has signed a consent form.

Exclusion criteria

• Subject is younger than 18 years
• Subject is unable to provide written informed consent
• Subject is incarcerated at the time of the study
• Subject is pregnant
• Subject is currently enrolled in a distinct study that might confound the results of the proposed study
• Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks

Trial design

30 participants in 1 patient group

Cardiac Surgery Patients

Description:

Patients undergoing cardiopulmonary bypass surgery, including placement of a ventricular access device.

Treatment:

Diagnostic Test: Quantra System