Thromboelastometry System Enables Rapid Assessment of Critical Bleeding at the POC – Surgical Techniques


Image: The ROTEM sigma thromboelastometry system provides fast results at the POC (Photo courtesy of Werfen)

For a clear picture of coagulopathy, a new thromboelastometry system provides at-a-glance assessment of clot firmness and stability, enabling optimization of hemostasis, while minimizing blood loss. The result is a reduction in inappropriate transfusions, associated complications and costs, all critical to the success of a patient blood management (PBM) program.

The ROTEM sigma thromboelastometry system from Werfen (Bedford, MA, USA) provides real-time, rapid and actionable results, now at the point-of-care (POC), to guide bleeding management. Built on proven cup-and-pin technology, the ROTEM sigma leverages similar assays to its predecessor, the ROTEM delta Thromboelastometry System, widely used in North America and in thousands of peer-reviewed clinical studies.

ROTEM sigma is fully integrated and automated, cartridge-based and simple to use, making it ideal for POC testing. Large, easy-to-view TEMograms provide clear, real-time viscoelastic test results for improved, fast interpretation. With a comprehensive test menu and four independent channels, the ROTEM sigma facilitates targeted therapy decisions in a variety of clinical settings. For critical procedures, including those requiring heparin neutralization, the ROTEM sigma complete + hep cartridge provides intraoperative results in cardiovascular surgery and liver transplantation.

Citrated whole blood arterial or venous samples require no incubation time and the test is initiated in minutes. First validated parameters, such as A5, are delivered faster than traditional methods, with actionable results in less than 15 minutes – essential in critical bleeding scenarios. Ready-to-use, room-temperature cartridges with integrated closed-tube sampling simplify testing, save time, and standardize the testing process.

Werfen’s new GEMweb Live real-time on-screen viewer consolidates diagnostic test results from ROTEM thromboelastometry systems. Quick, comprehensive test results displayed on a single screen help guide targeted therapy and other critical intraoperative needs, before, during, and after surgery, enabling faster clinical decision-making during cardiac surgery. Werfen has received 510(k) clearance from the United States Food and Drug Administration (FDA) for ROTEM sigma. With clinical use throughout Europe, Australia, Asia, Latin America and Africa, the ROTEM sigma will be commercialized in the United States in late 2022.

“Reducing inappropriate transfusions is paramount in today’s healthcare for patient safety, to help preserve the blood supply and to control costs. Integrating ROTEM sigma testing into a PBM program enables hospitals to achieve these goals,” said Remo Tazzi, Vice President, Worldwide Marketing and Service. , hemostasis and acute care diagnostics in Werfen. “By visualizing real-time, actionable results in the operating room, surgeons, anesthesiologists and other clinicians can make faster, more informed transfusion decisions, improving patient outcomes and improving the efficiency of the hospital.”

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