Quantra QPlus Sample Type Comparison

Completed

• Conditions: Coagulation Defect; Bleeding

• Registration Number: NCT05290675
• Lead Sponsor: HemoSonics LLC

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-11-04
• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-22
• Primary Completion: 2022-08-31
• Study Completion: 2022-11-02
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of QPlus Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples	During cardiac surgery	Measure of the shear modulus or strength/quality of the clot contributed by platelets determined using SEER sonorheometry assessed in two sample types
Comparison of QPlus Clot time (CT) in arterial and venous samples	During cardiac surgery	Coagulation function assessed in two sample types
Comparison of Clot stiffness (CS) determined with Quantra QPlus Cartridge in arterial and venous samples	During cardiac surgery	Measure of the overall shear modulus or strength/quality of the clot determined using SEER sonorheometry assessed in two sample types
Comparison of QPlus Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples	During cardiac surgery	Measure of the shear modulus or strength/quality of the clot contributed by fibrinogen determined using SEER sonorheometry assessed in two sample types
Comparison of QPlus Clot time with Heparinase (CTH) in arterial and venous samples	During cardiac surgery	Coagulation function assessed in two sample types

Trial Locations

Locations (1)

Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States