Cardiopulmonary Bypass
Conditions
Brief summary
This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in cardiac surgery patients.
Detailed description
HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia. Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients. A clinical study will be conducted to evaluate the analytical performance as well as provide a preliminary evaluation of the performance comparability of the HemoSonics' device as compared to existing coagulation monitoring technology in heart surgery. This study will be performed at HemoSonics and the Virginia Commonwealth University Medical Center and will involve patients undergoing cardiac surgery requiring bypass.
Interventions
DEVICECoagulation function
Coagulation function assessment tools TEG (standard of practice) vs SEER Quantra (novel coagulation function device)
Sponsors
HemoSonics LLC
Virginia Commonwealth University
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Subject is scheduled for cardiac surgery involving bypass circuit * Subject is older than 18 years * Subject is willing to participate and he/she has signed a consent form
Exclusion criteria
* Subject is unable to provide written informed consent * Subject is incarcerated at the time of the study * Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks * Patients on emergency cases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clot Time | 1 day | Coagulation Function assessed at 4 time points \[baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU\] over the course of cardiac surgery until patient ICU transfer |
| Clot Stiffness | 1 day | Coagulation Function assessed at 4 time points (baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU) over the course of cardiac surgery and bypass until patient ICU transfer |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cardiac Surgery Patients Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. Paired blood samples were assessed by thromboelastography (TEG; current care option) and by Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Surgery cancelled; no data | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Cardiac Surgery Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Clot Stiffness
Coagulation Function assessed at 4 time points (baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU) over the course of cardiac surgery and bypass until patient ICU transfer
Time frame: 1 day
Population: Matched paired blood samples evaluating coagulation function by two methods (TEG, SEER) for each patient at each of 4 time points \[baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU\]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardiac Surgery Patients | Clot Stiffness | TEG G force | 8.5 hPa | Standard Deviation 3.7 |
| Cardiac Surgery Patients | Clot Stiffness | SEER Clot stiffness | 18.4 hPa | Standard Deviation 9.2 |
Comparison: A cohort of 50 patients was estimated to capture at least 7 'bleeding' patients with a likelihood of 95%, assuming a 25% incidence of bleeding, and standard deviation of 20%, to determine maximum clot stiffness within +/- 10% of the mean. This was a descriptive and method-comparison study. Method comparisons were performed according to Clinical Laboratory Science Institute (CLSI) guidelines (Deming regression on paired measurements )p-value: <0.00195% CI: [2.9, 3.4]Deming regression
Primary
Clot Time
Coagulation Function assessed at 4 time points \[baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU\] over the course of cardiac surgery until patient ICU transfer
Time frame: 1 day
Population: Matched paired blood samples evaluating coagulation function by two methods (TEG, SEER) obtained from each patient at each sampling time (baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardiac Surgery Patients | Clot Time | Reaction Time R (TEG) | 4.9 min | Standard Deviation 1.2 |
| Cardiac Surgery Patients | Clot Time | Heparinase Clot Time (SEER) | 3.3 min | Standard Deviation 0.6 |
Comparison: A cohort of 50 patients was estimated to capture at least 7 'bleeding' patients with a likelihood of 95%, assuming a 25% incidence of bleeding, and standard deviation of 20%, to determine maximum clot stiffness within +/- 10% of the mean. This was a descriptive and method-comparison study. Method comparisons were performed according to Clinical Laboratory Science Institute (CLSI) guidelines (Deming regression on paired measurements)p-value: <0.00195% CI: [0.26, 0.44]Deming Regression