TY - JOUR
T1 - A comparison between the TEG 6s and TEG 5000 analyzers to assess coagulation in trauma patients
AU - Neal, Matthew D.
AU - Moore, Ernest E.
AU - Walsh, Mark
AU - Thomas, Scott
AU - Callcut, Rachael A.
AU - Kornblith, Lucy Z.
AU - Schreiber, Martin
AU - Ekeh, Akpofure Peter
AU - Singer, Adam J.
AU - Lottenberg, Lawrence
AU - Foreman, Michael
AU - Evans, Susan
AU - Winfield, Robert D.
AU - Goodman, Michael D.
AU - Freeman, Carl
AU - Milia, David
AU - Saillant, Noelle
AU - Hartmann, Jan
AU - Achneck, Hardean E.
N1 - Funding Information:
The authors would like to thank Zorayr Manukyan, PhD, ClinStatDevice LLC for support with statistical considerations for study design, data quality monitoring, analysis methodology and execution, and also to thank Elmar Reinhold Burchardt, MD, University of Witten-Herdecke, Germany for support of clinical trial conception and operations, data review and analysis, article review and editing. We thank Meridian HealthComms, Plumley, UK for providing medical writing support, which was funded by Haemonetics SA, Signy, Switzerland in accordance with Good Publication Practice (GPP3). Source of funding: This study was funded by Haemonetics Corporation, Braintree, USA. The data analysis was supported by a third party provider (ClinStatDevice LLC), funded by Haemonetics. Neither Drs. Neal, Moore, nor any of the co-authors received payment from Haemonetics for efforts associated with the article. The manuscript was drafted by Dr Neal, with support from Dr Moore and Dr Hartmann (Haemonetics). Medical writing support was funded by Haemonetics AS, Signy, Switzerland.
Funding Information:
MDN receives research support from the NIH and the United States Department of Defense. He receives research support from Janssen Pharmaceuticals, Haemonetics, Accriva Diagnostics, Instrument Laboratories, and Noveome Therapeutics. He has served as a paid scientific advisory board member to Janssen Pharmaceuticals and CSL Behring. E.E.M. received research support from Haemonetics for consumable supplies. M.W. and S.T. received research grants from Haemonetics for equipment, reagents and logistical and statistical support for research. R.A.C. received funding from Haemonetics for this research and receives funding for research from the NIH and DOD. L.Z.K. received funding from Haemonetics for this research and receives research support from the NIH. M.S. received consultancy payments from Haemonetics, Arsenal Medical and Velico Medical to his University. His university received funding from Haemonetics for this research. A.J.S. is on the speakers bureau for BMS, Pfizer, Janssen, and AstraZeneca. L.L. was previously a speaker for Haemonetics. R.D.W. is on the Editorial Board, Journal of Trauma and Acute Care Surgery (board service, no compensation) and the Editorial Board, SURGERY (honorarium for serving as Associate Editor for Social Media). N.S. received funding from Haemonetics for this research. J.H. and H.E.A. are or were employees of Haemonetics Corporation, Braintree, USA. For the remaining authors, no relevant conflicts were declared.
Publisher Copyright:
© 2020 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2020/2/1
Y1 - 2020/2/1
N2 - 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.
AB - 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.
KW - TEG 5000
KW - TEG 6s
KW - Thromboelastography
KW - trauma-induced coagulopathy
KW - viscoelastic testing
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U2 - 10.1097/TA.0000000000002545
DO - 10.1097/TA.0000000000002545
M3 - Article
C2 - 31738314
AN - SCOPUS:85077399772
SN - 2163-0755
VL - 88
SP - 279
EP - 285
JO - Journal of Trauma and Acute Care Surgery
JF - Journal of Trauma and Acute Care Surgery
IS - 2
ER -