Impact of Sample Type and Assay Time on the Performance of the Quantra QPlus System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- HemoSonics LLC
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Comparison of QPlus Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Comparison of QPlus Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: During cardiac surgery
Coagulation function assessed in two sample types
Secondary Outcomes
No secondary outcomes reported