Quantra QPlus Sample Type Comparison

HemoSonics

Status: Completed

Conditions: Coagulation Defect; Bleeding

Treatments: Diagnostic Test: Quantra QPlus System

Study type: Observational

Funder types: Industry

Identifiers

NCT05290675

HEMCS-042

Details and patient eligibility

About

This is a single center prospective observational study to compare QPlus parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing cardiac surgery.

Full description

In this single center prospective observational study, 40 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 120 matched samples for analysis on the Quantra System with the QPlus Cartridge.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 or subject's legally authorized representative is willing to participate and he/she has signed a consent formr.

Exclusion criteria

• Subject is younger than 18 years
• Subject is pregnant
• Subject is incarcerated at the time of the study
• Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks
• Subject, or subject's legally aurthorized representative is able to provide written informed consent