Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery

HemoSonics LLC40 enrolled

Overview

This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.

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 in parallel yielding six parameters that depict the functional status of a patient's coagulation system. This single-site, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using TEG in patients taking antiplatelet medication that are scheduled to undergo cardiac surgery.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Blood Loss, Surgical

Interventions

Quantra SystemDIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is scheduled for elective cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular assist device * Subject was identified as taking antiplatelet medication, specifically a P2Y12 inhibitor such that a TEG Platelet Mapping test is prescribed prior to surgery to assess possible platelet inhibition * Subject is ≥ 18 years * Subject is willing to participate and he/she has signed a consent form Exclusion Criteria: * Subject is younger that 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.

Locations (1)

Huntsville Hospital

Huntsville, Alabama, United States

Outcomes

Primary Outcomes

Comparison of Quantra Clot Time test results to TEG test results.

Coagulation function assessed by Quantra and TEG.

Time frame: Prior to surgery (Baseline)

Comparison of Quantra Clot Stiffness test results to TEG test results.

Coagulation function assessed by Quantra and TEG.

Time frame: Prior to surgery (Baseline)

Comparison of Quantra Clot Time and Clot Stiffness test results to TEG test results.

Coagulation function assessed by Quantra and TEG.

Time frame: Post-bypass (10 to 20 minutes after protamine administration).

Comparison of Quantra Clot Time test results to TEG test results.

Coagulation function assessed by Quantra and TEG.

Time frame: Post-bypass (10 to 20 minutes after protamine administration).

Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen

Coagulation function assessed by Quantra and laboratory fibrinogen testing

Time frame: Prior to surgery (Baseline)

Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen

Coagulation function assessed by Quantra and laboratory fibrinogen testing

Time frame: Post-bypass (10 to 20 minutes after protamine administration).

Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count

Coagulation function assessed by Quantra and laboratory fibrinogen testing

Time frame: Post-bypass (10 to 20 minutes after protamine administration).

Data from ClinicalTrials.gov

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