Critical Bleeding Management System to Help Hospitals Further Standardize Viscoelastic Testing

By LabMedica International staff writers
Posted on 05 Apr 2024

Image: The Quantra Hemostasis System has received US FDA special 510(k) clearance for use with its Quantra QStat Cartridge (Photo courtesy of HemoSonics)

Surgical procedures are often accompanied by significant blood loss and the subsequent high likelihood of the need for allogeneic blood transfusions. These transfusions, while critical, are linked to various adverse clinical outcomes, including the need for reoperations due to bleeding. Current treatment options for coagulopathic bleeding include a range of allogeneic blood components and pharmacological agents, but their effective application depends upon the availability of accurate and prompt diagnostic tests. These tests are essential for selecting the appropriate treatment needs, thereby curtailing unnecessary transfusions, minimizing waste of blood products, cutting healthcare costs, and ultimately enhancing patient care. Implementing patient blood management strategies plays a pivotal role in maintaining hemostasis, reducing bleeding, and lowering the transfusion requirement. Now, a cartridge-based device with unique ultrasound technology that can measure the viscoelastic properties of whole blood during coagulation provides comprehensive blood analysis, helping clinicians manage patients back into hemostasis.

The Quantra hemostasis analyzer from HemoSonics (Durham, NC, USA), part of the Stago Group, empowers healthcare professionals to make individualized, evidence-driven decisions on managing bleeding patients, ensuring that the administered treatments are suitable and in line with global initiatives to reduce inappropriate transfusions of blood products. The Quantra hemostasis system, comprising the Quantra hemostasis analyzer along with the QPlus and QStat cartridges, facilitates decision-making on bleeding management, thereby elevating patient care and enhancing the efficiency of blood product utilization. Designed for ease of maintenance and simple operation and interpretation, the Quantra System delivers rapid, in-depth whole-blood coagulation assessments either at the point of care or in lab settings, producing results in under 15 minutes.

Granted clearance by the U.S. Food and Drug Administration (FDA) for use in critical care settings, including operating rooms, ICUs, and hospital labs, the Quantra system enables hospitals to standardize use institution-wide with higher operational efficiency. The QStat cartridge for use with the Quantra hemostasis analyzer was first approved by the FDA in 2022 for processing venous whole blood samples. HemoSonics has now been granted Special 510(k) clearance by the FDA for the expanded use of arterial blood samples with its Quantra QStat cartridge, allowing hospitals to further standardize and operationalize viscoelastic testing with an arterial and venous indication for both HemoSonics' QStat Cartridge and the QPlus cartridges.

"The FDA 510(k) clearance for arterial blood sample use with our QStat Cartridge will make it easier and more convenient for hospitals to use the Quantra System," said Bob Roda, President and CEO of HemoSonics. "The Quantra System now has the broadest range of FDA-cleared clinical indications of any cartridge-based viscoelastic testing system. It is cleared for use in cardiac, trauma, liver, and major orthopedic surgeries. We will continue to innovate in our mission to help patients and hospitals preserve blood, which is a precious resource."