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

Publication ,  Journal Article
Groves, DS; Welsby, IJ; Naik, BI; Tanaka, K; Hauck, JN; Greenberg, CS; Winegar, DA; Viola, F
Published in: Anesth Analg
April 2020

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.

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Published In

Anesth Analg

DOI

EISSN

1526-7598

Publication Date

April 2020

Volume

130

Issue

4

Start / End Page

899 / 909

Location

United States

Related Subject Headings

  • Whole Blood Coagulation Time
  • Thrombelastography
  • Reproducibility of Results
  • ROC Curve
  • Prospective Studies
  • Platelet Count
  • Monitoring, Intraoperative
  • Middle Aged
  • Male
  • Humans
 

Citation

APA
Chicago
ICMJE
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Groves, D. S., Welsby, I. J., Naik, B. I., Tanaka, K., Hauck, J. N., Greenberg, C. S., … Viola, F. (2020). Multicenter Evaluation of the Quantra QPlus System in Adult Patients Undergoing Major Surgical Procedures. Anesth Analg, 130(4), 899–909. https://doi.org/10.1213/ANE.0000000000004659
Groves, Danja S., Ian J. Welsby, Bhiken I. Naik, Kenichi Tanaka, Jennifer N. Hauck, Charles S. Greenberg, Deborah A. Winegar, and Francesco Viola. “Multicenter Evaluation of the Quantra QPlus System in Adult Patients Undergoing Major Surgical Procedures.Anesth Analg 130, no. 4 (April 2020): 899–909. https://doi.org/10.1213/ANE.0000000000004659.
Groves DS, Welsby IJ, Naik BI, Tanaka K, Hauck JN, Greenberg CS, et al. Multicenter Evaluation of the Quantra QPlus System in Adult Patients Undergoing Major Surgical Procedures. Anesth Analg. 2020 Apr;130(4):899–909.
Groves, Danja S., et al. “Multicenter Evaluation of the Quantra QPlus System in Adult Patients Undergoing Major Surgical Procedures.Anesth Analg, vol. 130, no. 4, Apr. 2020, pp. 899–909. Pubmed, doi:10.1213/ANE.0000000000004659.
Groves DS, Welsby IJ, Naik BI, Tanaka K, Hauck JN, Greenberg CS, Winegar DA, Viola F. Multicenter Evaluation of the Quantra QPlus System in Adult Patients Undergoing Major Surgical Procedures. Anesth Analg. 2020 Apr;130(4):899–909.

Published In

Anesth Analg

DOI

EISSN

1526-7598

Publication Date

April 2020

Volume

130

Issue

4

Start / End Page

899 / 909

Location

United States

Related Subject Headings

  • Whole Blood Coagulation Time
  • Thrombelastography
  • Reproducibility of Results
  • ROC Curve
  • Prospective Studies
  • Platelet Count
  • Monitoring, Intraoperative
  • Middle Aged
  • Male
  • Humans