Coagulation Defect; Bleeding
Conditions
Keywords
Cardiac surgery, Quantra, Viscoelastic testing, Coagulation
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.
Interventions
DIAGNOSTIC_TESTQuantra QPlus System
Whole blood coagulation testing system
Sponsors
HemoSonics LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of QPlus Clot time (CT) in arterial and venous samples | During cardiac surgery | Coagulation function 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 |
| 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 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 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 |
Countries
United States
Outcome results
None listed