Evaluation of the Quantra System in a Surgical Oncological Population

Completed

• Conditions: Blood Loss, Surgical
• Interventions: Diagnostic Test: Quantra System

• Registration Number: NCT04116385
• Lead Sponsor: HemoSonics LLC

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.

Study Timeline

• Study Start: 2019-08-15
• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-04
• Primary Completion: 2020-03-12
• Study Completion: 2020-07-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer surgery patients	Quantra System	Adult subjects (18 years or older) undergoing an oncologic surgical procedure.

Primary Outcome Measures

Name	Time	Method
Comparison of Quantra Clot Time results to TEG R results	Post-surgery, while patient is in the ICU/PACU, usually within 24 hours of surgery	Coagulation function assessed by Quantra and TEG 5000
Comparison of Quantra Time results to TEG R results	During surgery	Coagulation function assessed by Quantra and TEG 5000
Comparison of Quantra Clot Stiffness results to TEG MA results	Post-surgery, while patient is in the ICU/PACU, usually within 24 hours of surgery	Coagulation function assessed by Quantra and TEG 5000

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States