Clinical trial NCT03988465: HemoSonics - UTMB Cardiac Surgery Study
Official title: HemoSonics - UTMB Cardiac Surgery Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Loss, Surgical
Keywords: Viscoelastic testing
Coagulation
Quantra
Hemostasis
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
First posted: 2019-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes subjects 18 years or older undergoing cardiac surgery utilizing cardiopulmonary bypass, including placement of a ventricular access device.

Brief summary: This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra QPlus Cartridge in patients undergoing cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.

Detailed description: The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, and ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra QPlus Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system.

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.

Eligibility criteria: Inclusion Criteria:

* Subject is ≥ 18 years
* 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 younger than 18 years
* 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

Primary outcomes:
measure: Comparison of Quantra Clot Time results to TEG R results
timeFrame: Baseline, defined as after induction of anesthesia but before surgical incision
measure: Comparison of Quantra Clot Stiffness results to TEG MA results
timeFrame: Baseline, defined as after induction of anesthesia but before surgical incision
measure: Comparison of Quantra Clot Time results to TEG R results
timeFrame: During bypass
measure: Comparison of Quantra Clot Stiffness results to TEG MA results
timeFrame: During bypass
measure: Comparison of Quantra Clot Time results to TEG R results
timeFrame: Post-bypass, defined as 10 to 20 minutes after protamine administration
measure: Comparison of Quantra Clot Stiffness results to TEG MA results
timeFrame: Post-bypass, defined as 10 to 20 minutes after protamine administration
measure: Comparison of Quantra Clot Time results to standard coagulation test results (aPTT)
timeFrame: Baseline, defined as after induction of anesthesia but before surgical incision
measure: Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results
timeFrame: Baseline, defined as after induction of anesthesia but before surgical incision
measure: Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count
timeFrame: Baseline, defined as after induction of anesthesia but before surgical incision
measure: Comparison of Quantra Clot Time results to standard coagulation test results (aPTT)
timeFrame: During bypass
measure: Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results
timeFrame: During bypass
measure: Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count
timeFrame: During bypass
measure: Comparison of Quantra Clot Time results to standard coagulation test results (aPTT)
timeFrame: Post-bypass, defined as 10 to 20 minutes after protamine administration
measure: Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results
timeFrame: Post-bypass, 10 to 20 minutes after protamine
measure: Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count
timeFrame: Post-bypass, defined as 10 to 20 minutes after protamine administration
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
References: