Ernest E Moore, Edward A Michelson, Katrina Gabriel-Ramos, Michael W Cripps, Antolin Flores, Kofi Vandyck, Brian Thurston, Meghan Brennan, Francesco Viola, Deborah A Winegar
{"title":"QStat卡带在成人创伤患者中的多中心评价。","authors":"Ernest E Moore, Edward A Michelson, Katrina Gabriel-Ramos, Michael W Cripps, Antolin Flores, Kofi Vandyck, Brian Thurston, Meghan Brennan, Francesco Viola, Deborah A Winegar","doi":"10.1136/tsaco-2024-001672","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Trauma-induced coagulopathy (TIC) occurs in a quarter of trauma patients and is associated with death due to uncontrolled bleeding. Current guidelines recommend viscoelastic testing (VET) to assess coagulopathy and guide transfusions. The Quantra with the QStat Cartridge is a point-of-care (POC) VET device that measures changes in clot stiffness (CS) during coagulation and fibrinolysis using ultrasound detection of resonance. This study aimed to evaluate the performance of the QStat Cartridge in trauma patients compared with rotational thromboelastometry (ROTEM) <i>delta</i> and thromboelastography (TEG) 6s VET devices.</p><p><strong>Methods: </strong>A multicenter prospective observational study was conducted in adult patients meeting criteria for a full trauma team response at eight US level 1 trauma centers. Citrated blood samples drawn on arrival at the hospital or after blood transfusions were analyzed in parallel on QStat, ROTEM or TEG. Correlation between QStat and equivalent VET measurements was assessed by linear regression. Concordance was assessed by agreement of results relative to device-specific normal reference ranges.</p><p><strong>Results: </strong>259 severely injured patients were enrolled, yielding 271 samples for analysis. Moderate to strong correlations between QStat and corresponding ROTEM and TEG measurements were observed (r=0.64-0.88). The concordance between CS results was 84.5% for QStat CS and EXTEM A10 and 83.3% for CS and citrated rapid TEG maximum amplitude. For fibrinogen-related results, concordance was 81.5% for QStat fibrinogen contribution to clot stiffness (FCS) and FIBTEM A10 and 93.8% for FCS and citrated functional fibrinogen maximum amplitude. For fibrinolysis measurements, the overall agreement between QStat clot stability to lysis and EXTEM ML or CK-LY30 was 97.5% and 92.9%, respectively.</p><p><strong>Conclusion: </strong>QStat provides comparable information to the ROTEM <i>delta</i> and TEG 6s in trauma patients and can be useful for diagnosing TIC and guiding treatment. The Quantra's simplicity of use, ability to deploy at the POC, and rapid availability of results may provide clinicians with a faster, more convenient means to assess and manage TIC.</p><p><strong>Level of evidence: </strong>Diagnostic test, level II.</p><p><strong>Trial registration number: </strong>NCT04312958.</p>","PeriodicalId":23307,"journal":{"name":"Trauma Surgery & Acute Care Open","volume":"10 2","pages":"e001672"},"PeriodicalIF":2.1000,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12142034/pdf/","citationCount":"0","resultStr":"{\"title\":\"Multicenter evaluation of the Quantra with the QStat Cartridge in adult trauma patients.\",\"authors\":\"Ernest E Moore, Edward A Michelson, Katrina Gabriel-Ramos, Michael W Cripps, Antolin Flores, Kofi Vandyck, Brian Thurston, Meghan Brennan, Francesco Viola, Deborah A Winegar\",\"doi\":\"10.1136/tsaco-2024-001672\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Trauma-induced coagulopathy (TIC) occurs in a quarter of trauma patients and is associated with death due to uncontrolled bleeding. Current guidelines recommend viscoelastic testing (VET) to assess coagulopathy and guide transfusions. The Quantra with the QStat Cartridge is a point-of-care (POC) VET device that measures changes in clot stiffness (CS) during coagulation and fibrinolysis using ultrasound detection of resonance. This study aimed to evaluate the performance of the QStat Cartridge in trauma patients compared with rotational thromboelastometry (ROTEM) <i>delta</i> and thromboelastography (TEG) 6s VET devices.</p><p><strong>Methods: </strong>A multicenter prospective observational study was conducted in adult patients meeting criteria for a full trauma team response at eight US level 1 trauma centers. Citrated blood samples drawn on arrival at the hospital or after blood transfusions were analyzed in parallel on QStat, ROTEM or TEG. Correlation between QStat and equivalent VET measurements was assessed by linear regression. Concordance was assessed by agreement of results relative to device-specific normal reference ranges.</p><p><strong>Results: </strong>259 severely injured patients were enrolled, yielding 271 samples for analysis. Moderate to strong correlations between QStat and corresponding ROTEM and TEG measurements were observed (r=0.64-0.88). The concordance between CS results was 84.5% for QStat CS and EXTEM A10 and 83.3% for CS and citrated rapid TEG maximum amplitude. For fibrinogen-related results, concordance was 81.5% for QStat fibrinogen contribution to clot stiffness (FCS) and FIBTEM A10 and 93.8% for FCS and citrated functional fibrinogen maximum amplitude. For fibrinolysis measurements, the overall agreement between QStat clot stability to lysis and EXTEM ML or CK-LY30 was 97.5% and 92.9%, respectively.</p><p><strong>Conclusion: </strong>QStat provides comparable information to the ROTEM <i>delta</i> and TEG 6s in trauma patients and can be useful for diagnosing TIC and guiding treatment. The Quantra's simplicity of use, ability to deploy at the POC, and rapid availability of results may provide clinicians with a faster, more convenient means to assess and manage TIC.</p><p><strong>Level of evidence: </strong>Diagnostic test, level II.</p><p><strong>Trial registration number: </strong>NCT04312958.</p>\",\"PeriodicalId\":23307,\"journal\":{\"name\":\"Trauma Surgery & Acute Care Open\",\"volume\":\"10 2\",\"pages\":\"e001672\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2025-06-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12142034/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Trauma Surgery & Acute Care Open\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1136/tsaco-2024-001672\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"CRITICAL CARE MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Trauma Surgery & Acute Care Open","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1136/tsaco-2024-001672","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"CRITICAL CARE MEDICINE","Score":null,"Total":0}
Multicenter evaluation of the Quantra with the QStat Cartridge in adult trauma patients.
Background: Trauma-induced coagulopathy (TIC) occurs in a quarter of trauma patients and is associated with death due to uncontrolled bleeding. Current guidelines recommend viscoelastic testing (VET) to assess coagulopathy and guide transfusions. The Quantra with the QStat Cartridge is a point-of-care (POC) VET device that measures changes in clot stiffness (CS) during coagulation and fibrinolysis using ultrasound detection of resonance. This study aimed to evaluate the performance of the QStat Cartridge in trauma patients compared with rotational thromboelastometry (ROTEM) delta and thromboelastography (TEG) 6s VET devices.
Methods: A multicenter prospective observational study was conducted in adult patients meeting criteria for a full trauma team response at eight US level 1 trauma centers. Citrated blood samples drawn on arrival at the hospital or after blood transfusions were analyzed in parallel on QStat, ROTEM or TEG. Correlation between QStat and equivalent VET measurements was assessed by linear regression. Concordance was assessed by agreement of results relative to device-specific normal reference ranges.
Results: 259 severely injured patients were enrolled, yielding 271 samples for analysis. Moderate to strong correlations between QStat and corresponding ROTEM and TEG measurements were observed (r=0.64-0.88). The concordance between CS results was 84.5% for QStat CS and EXTEM A10 and 83.3% for CS and citrated rapid TEG maximum amplitude. For fibrinogen-related results, concordance was 81.5% for QStat fibrinogen contribution to clot stiffness (FCS) and FIBTEM A10 and 93.8% for FCS and citrated functional fibrinogen maximum amplitude. For fibrinolysis measurements, the overall agreement between QStat clot stability to lysis and EXTEM ML or CK-LY30 was 97.5% and 92.9%, respectively.
Conclusion: QStat provides comparable information to the ROTEM delta and TEG 6s in trauma patients and can be useful for diagnosing TIC and guiding treatment. The Quantra's simplicity of use, ability to deploy at the POC, and rapid availability of results may provide clinicians with a faster, more convenient means to assess and manage TIC.
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