Quantra QPlus Sample Type Comparison

Coagulation Defect; Bleeding Clinical Trial

Official title:

Impact of Sample Type and Assay Time on the Performance of the Quantra QPlus System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05290675
• Other study ID #: HEMCS-042
• Status: Completed
• Start date: November 4, 2021
• Est. completion date: November 2, 2022

Study information

• Verified date: April 2023
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Defect; Bleeding
• Hemostatic Disorders

Intervention

Diagnostic Test:
• Quantra QPlus System
Whole blood coagulation testing system

Locations

Country	Name	City	State
United States	Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
HemoSonics LLC

Country where clinical trial is conducted

United States, 

Outcome

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