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| Name | Class |
|---|---|
| HemoSonics LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Surgery Patients | Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coagulation function | Device | Coagulation function assessment tools TEG (standard of practice) vs SEER Quantra (novel coagulation function device) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day |
| 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 | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Participants for this study will be recruited at the Virginia Commonwealth University Medical Center. The subject population will be representative of the local racial and ethnic population.
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Speiss, M.D. | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardiac Surgery Patients | Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU. Blood specimen collection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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) | Posted | Mean | Standard Deviation | min | 1 day | blood samples | Participants |
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one day
'Bleeding' was defined as chest tube drainage > 1500 mL in 24 hr; serious bleeding was defined as necessitating a return to the operating room for re-exploration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cardiac Surgery Patients | Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry Blood specimen collection |
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This is a descriptive, single-cohort study, not an hypothesis-testing trial. The objective was device performance comparison. As there is no gold standard technology, this study could not determine which method was 'best' or 'superior'.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Bruce Spiess, Principal Investigator | Virginia Commonwealth University | 804-828-2267 | bruce.spiess@vcuhealth.org |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | 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] | Posted | Mean | Standard Deviation | hPa | 1 day | blood samples | Participants |
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| 0 |
| 50 |
| 0 |
| 50 |
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Slope measured deviation from 1:1 concordance between SEER and TEG with TEG as denominator. Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients |
| No |
| Superiority or Other |