Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2019-06-19
2020-05-15
Brief Summary
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Detailed Description
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This single-center, prospective, observational study will evaluate the performance of the Quantra System as compared to and comparable measures determined using the TEG 5000.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cardiac Surgery Patients
Patients undergoing cardiopulmonary bypass surgery, including placement of a ventricular access device.
Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Interventions
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Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is scheduled for cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.
* 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 pregnant
* Subject is currently enrolled in a distinct study that might confound the results of the proposed study
* Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks
18 Years
ALL
No
Sponsors
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HemoSonics LLC
INDUSTRY
Responsible Party
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Locations
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University of Texas Medical Branch
Galveston, Texas, United States
Countries
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Other Identifiers
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HEMCS-024
Identifier Type: -
Identifier Source: org_study_id
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