دورية أكاديمية

Multicenter Evaluation of the Quantra QPlus System in Adult Patients Undergoing Major Surgical Procedures.

التفاصيل البيبلوغرافية
العنوان: Multicenter Evaluation of the Quantra QPlus System in Adult Patients Undergoing Major Surgical Procedures.
المؤلفون: Groves DS; From the Department of Anesthesiology, University of Virginia, Charlottesville, Virginia., Welsby IJ; Department of Anesthesiology, Duke University, Durham, North Carolina., Naik BI; From the Department of Anesthesiology, University of Virginia, Charlottesville, Virginia., Tanaka K; Department of Anesthesiology, University of Maryland, Baltimore, Maryland., Hauck JN; Department of Anesthesiology, Duke University, Durham, North Carolina., Greenberg CS; Department of Hematology/Oncology, Medical University of South Carolina, Charleston, South Carolina., Winegar DA; HemoSonics, LLC, Charlottesville, Virginia, and Durham, North Carolina., Viola F; HemoSonics, LLC, Charlottesville, Virginia, and Durham, North Carolina.
المصدر: Anesthesia and analgesia [Anesth Analg] 2020 Apr; Vol. 130 (4), pp. 899-909.
نوع المنشور: Journal Article; Multicenter Study; Observational Study; Research Support, N.I.H., Extramural
اللغة: English
بيانات الدورية: Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 1310650 Publication Model: Print Cited Medium: Internet ISSN: 1526-7598 (Electronic) Linking ISSN: 00032999 NLM ISO Abbreviation: Anesth Analg Subsets: MEDLINE
أسماء مطبوعة: Publication: 1998- : Baltimore, Md. : Lippincott Williams & Wilkins
Original Publication: Cleveland, International Anesthesia Research Society.
مواضيع طبية MeSH: Blood Coagulation*, Blood Coagulation Tests/*instrumentation , Cardiac Surgical Procedures/*methods , Monitoring, Intraoperative/*instrumentation , Thrombelastography/*instrumentation, Adult ; Aged ; Aged, 80 and over ; Algorithms ; Blood Coagulation Tests/methods ; Blood Loss, Surgical ; Blood Viscosity ; Cardiopulmonary Bypass ; Elasticity ; Female ; Fibrinogen/analysis ; Humans ; Male ; Middle Aged ; Monitoring, Intraoperative/methods ; Platelet Count ; Prospective Studies ; ROC Curve ; Reproducibility of Results ; Thrombelastography/methods ; Whole Blood Coagulation Time
مستخلص: Background: The management of perioperative bleeding and the optimization of the available therapies are subjects of significant clinical interest. Clinical guidelines recommend the use of whole blood viscoelastic testing devices to target the utilization of blood products during major surgical procedures. The Quantra QPlus System is a new cartridge-based viscoelastic testing device based on an innovative ultrasound technology. The aim of this study was to evaluate this new system in a surgical population.
Methods: Two hundred seventy-seven adult subjects were enrolled in a multicenter, prospective observational study consisting primarily of patients undergoing cardiac and major orthopedic surgeries. Samples were obtained at multiple time points for testing on the Quantra QPlus System, the rotational thromboelastometry (ROTEM) delta, and standard coagulation tests. Quantra measurements included Clot Time (CT), Heparinase Clot Time (CTH), Clot Time Ratio (CTR), Clot Stiffness (CS), Fibrinogen (FCS), and Platelet (PCS) Contributions to CS. Data analyses included assessment of the concordance of Quantra parameters with a series of clinical composite indexes formed on the basis of standard coagulation tests in 3 domains representing increased, decreased, and normal/subclinical coagulation function. Linear regression and receiver operator characteristic (ROC) analyses of Quantra parameters with corresponding parameters from ROTEM assays were also performed.
Results: The accuracy (overall percent agreement or ratio of true positives and true negatives over the entire population) between the Quantra and the composite indexes was between 72% and 98% depending on the specific parameter. Linear regression analysis indicated that the correlation between ROTEM delta and Quantra was very strong with r values ranging between 0.84 and 0.89. Results from ROC analysis demonstrated sensitivities and specificities in the 80%-90% range when QPlus parameters were used to discriminate ROTEM threshold values currently used in goal-directed treatment algorithms.
Conclusions: This study demonstrated that the Quantra QPlus System is strongly correlated with a well-established viscoelastic testing device and its parameters effectively represent the results from multiple standard laboratory assays. The Quantra has been designed to operate at the point of care with the potential to provide rapid and comprehensive results to aid in the management of coagulopathic patients.
معلومات مُعتمدة: R01 HL121232 United States HL NHLBI NIH HHS
المشرفين على المادة: 9001-32-5 (Fibrinogen)
تواريخ الأحداث: Date Created: 20200208 Date Completed: 20200507 Latest Revision: 20200507
رمز التحديث: 20221213
DOI: 10.1213/ANE.0000000000004659
PMID: 32032102
قاعدة البيانات: MEDLINE
الوصف
تدمد:1526-7598
DOI:10.1213/ANE.0000000000004659