Evaluation of the Quantra System in a Surgical Oncological Population

HemoSonics

Status: Completed

Conditions: Blood Loss, Surgical

Treatments: Diagnostic Test: Quantra System

Study type: Observational

Funder types: Industry

Identifiers

NCT04116385

HEMCS-025

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

75 participants in 1 patient group

Cancer surgery patients

Description:

Adult subjects (18 years or older) undergoing an oncologic surgical procedure.

Treatment:

Diagnostic Test: Quantra System