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From the Departments of Surgery, Critical Care Medicine, and the Clinical and Translational Science Institute (CTSI) (M.D.N.), University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Ernest E Moore Shock Trauma Center at Denver Health (E.E.M.), Denver, Colorado; Memorial Hospital of South Bend (M.W., S.T.), South Bend, Indiana; Department of Surgery (R.A.C., L.Z.K.), Zuckerberg San Francisco General Hospital, University of California San Francisco (UCSF), San Francisco, California; Division of Trauma, Critical Care & Acute Care Surgery, Department of Surgery (M.S.), Oregon Health & Science University, Portland, Oregon; Wright State University (A.P.E.), Dayton, Ohio; Stony Brook Department of Emergency Medicine (A.J.S.), Stony Brook University, Stony Brook, New York; Department of Surgery, Florida Atlantic University, St. Mary's Medical Center (L.L.), West Palm Beach, Florida; Division of Trauma, Acute Care, and Critical Care Surgery (M.F.), Baylor University Medical Center, Dallas, Texas; Division of Acute Care Surgery, Department of Surgery (S.E.), Carolinas Medical Center, Charlotte, North Carolina; University of Kansas Medical Center (R.D.W.), University of Kansas, Kansas City, Kansas; Department of Surgery (M.D.G.), University of Cincinnati, Cincinnati, Ohio; SSM Health (C.F.), Saint Louis University Hospital, St Louis, Missouri; Division of Trauma and Acute Care Surgery (D.M.), Medical College of Wisconsin, Milwaukee, Wisconsin; Department of Surgery (N.S.), Massachusetts General Hospital, Boston; and Haemonetics Corporation (J.H., H.E.A.), Braintree, Massachusetts.
Published: February 2020
AI Article Synopsis
Article Abstract
Background: Trauma-induced coagulopathy is a major driver of mortality following severe injury. Viscoelastic goal-directed resuscitation can reduce mortality after injury. The TEG 5000 system is widely used for viscoelastic testing. However, the TEG 6s system incorporates newer technology, with encouraging results in cardiovascular interventions. The purpose of this study was to validate the TEG 6s system for use in trauma patients.
Methods: Multicenter noninvasive observational study for method comparison conducted at 12 US Levels I and II trauma centers. Agreement between the TEG 6s and TEG 5000 systems was examined using citrated kaolin reaction time (CK.R), citrated functional fibrinogen maximum amplitude (CFF.MA), citrated kaolin percent clot lysis at 30 minutes (CK.LY30), citrated RapidTEG maximum amplitude (CRT.MA), and citrated kaolin maximum amplitude (CK.MA) parameters in adults meeting full or limited trauma team criteria. Blood was drawn ≤1 hour after admission. Assays were repeated in duplicate. Reliability (TEG 5000 vs. TEG 6s analyzers) and repeatability (interdevice comparison) was quantified. Linear regression was used to define the relationship between TEG 6s and TEG 5000 devices.
Results: A total of 475 patients were enrolled. The cohort was predominantly male (68.6%) with a median age of 49 years. Regression line slope estimates (ß) and linear correlation estimates (p) were as follows: CK.R (ß = 1.05, ρ = 0.9), CFF.MA (ß = 0.99, ρ = 0.95), CK.LY30 (ß = 1.01, ρ = 0.91), CRT.MA (TEG 6s) versus CK.MA (TEG 5000) (ß = 1.06, ρ = 0.86) as well as versus CRT.MA (TEG 5000) (ß = 0.93, ρ = 0.93), indicating strong reliability between the devices. Overall, within-device repeatability was better for TEG 6s versus TEG 5000, particularly for CFF.MA and CK.LY30.
Conclusion: The TEG 6s device appears to be highly reliable for use in trauma patients, with close correlation to the TEG 5000 device and equivalent/improved within-device reliability. Given the potential advantages of using the TEG 6s device at the site of care, confirmation of agreement between the devices represents an important advance in diagnostic testing.
