Coagulation Defect; Bleeding
Conditions
Keywords
Quantra, Liver transplantation, Coagulation
Brief summary
This is a single center prospective observational study to compare QStat parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing liver transplantation.
Detailed description
In this single center prospective observational study, 25 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 75 matched samples for analysis on the Quantra System with the QStat Cartridge.
Interventions
DEVICEDiagnostic Test: Quantra QStat Cartridge
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 \>=18 years * Subject is scheduled for liver transplant surgery * Subject or subject's legally authorized representative (LAR) is willing to provide informed consent
Exclusion criteria
* Subject is younger than 18 years of age * Subject is pregnant * Subject is incarcerated at the time of the study * Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks * Subject, or subject's LAR, is unable or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of QStat Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples | During liver transplantation surgery | Coagulation function assessed in two sample types |
| Comparison of QStat Clot time (CT) in arterial and venous samples | During liver transplantation surgery | Coagulation function assessed in two sample types |
| Comparison of QStat Clot stiffness (CS) in arterial and venous samples | During liver transplantation surgery | Coagulation function assessed in two sample types |
| Comparison of QStat Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples | During liver transplantation surgery | Coagulation function assessed in two sample types |
| Comparison of QStat Clot Stabilty to Lysis (CSL) in arterial and venous samples | During liver transplantation surgery | Coagulation function assessed in two sample types |
Countries
United States
Outcome results
None listed