NCT04116385

Evaluation of the Quantra System in a Surgical Oncological Population

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• Sponsor: HemoSonics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blood Loss, Surgical

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Quantra System	Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Timeline

• Start date: 2019-08-15
• Primary completion: 2020-03-12
• Completion: 2020-07-30
• First posted: 2019-10-04
• Last updated: 2020-09-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study