Clinical trial NCT04116385: Evaluation of the Quantra System in a Surgical Oncological Population
Official title: Evaluation of the Quantra System in a Surgical Oncological Population
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: 2019-10-04
Enrollment: 75
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 adult subjects undergoing an oncologic surgical procedure.

Brief summary: This study will monitor coagulation parameters during the perioperative course of cancer surgical procedures using the Quantra System with the QPlus Cartridge.

Detailed description: The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an 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 iin parallel yielding six parameters that depict the functional status of a patient's coagulation system.

The oncologic surgical population presents unique challenges to providers who must distinguish between a cancer patient's increased tendency toward both thrombosis and hemorrhage. This single site prospective observational study in oncologic patients will give an insight into the coagulation status of critically ill cancer patients.

Eligibility criteria: Inclusion Criteria:

* Subject is \>= 18 years
* Subject is diagnosed with cancer and is scheduled for surgical resection
* Subject is willing to participate, and he/she or a Legally Authorized Representative (LAR) has signed a consent form
* Surgical procedure to be performed has an anticipated blood loss (\>500mL) based on historical data

Exclusion Criteria:

* Subject is younger than 18 years
* Subject or a subject's LAR is unable to provide written informed consent
* Subject is undergoing an emergent procedure.
* Subject is pregnant, has active liver disease, or severe renal dysfunction (creatinine clearance (CrCL)\<30 mL/min)
* Subject has an extremely low platelet count (\<40,000/uL)
* 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, before surgical incision
measure: Comparison of Quantra Clot Stiffness results to TEG MA results
timeFrame: Baseline, defined as after induction of anesthesia, before surgical incision
measure: Comparison of Quantra Time results to TEG R results
timeFrame: During surgery
measure: Comparison of Quantra Clot Stiffness results to TEG MA results
timeFrame: During surgery
measure: Comparison of Quantra Clot Time results to TEG R results
timeFrame: Post-surgery, while patient is in the ICU/PACU, usually within 24 hours of surgery
measure: Comparison of Quantra Clot Stiffness results to TEG MA results
timeFrame: Post-surgery, while patient is in the ICU/PACU, usually within 24 hours of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
References: