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Abstract
Background Whole blood viscoelastic testing (VET) devices are routinely used in a variety of clinical settings to assess hemostasis. The Quantra QStat System is a cartridge-based point of care VET device that measures changes in clot stiffness during coagulation and fibrinolysis using ultrasound detection of resonance. The objective of this study was to assess the ability of the Quantra QStat System to detect coagulopathies in trauma patients.
Methods A multicenter observational study was conducted on adult subjects at two level 1 trauma centers. For each subject, whole blood samples were drawn upon arrival to the emergency department and again, in some cases, after administration of blood products and/or antifibrinolytics. Samples were analyzed on the Quantra in parallel to ROTEM delta. The QStat cartridge provides measures of Clot Time (CT), Clot Stiffness (CS), Fibrinogen and Platelet Contributions to clot stiffness (FCS and PCS), and Clot Stability to Lysis (CSL). Data analyses included linear regression of Quantra and ROTEM parameters and an assessment of the concordance of the two devices for the assessment of hyperfibrinolysis.
Results A total of 56 patients were analyzed. 42% of samples had a low QStat CS value suggestive of an hypocoagulable state. The low stiffness values could be attributed to either low PCS, FCS or combination. Additionally, 13% of samples showed evidence of hyperfibrinolysis based on the QStat CSL parameter. Samples analyzed with ROTEM assays showed a lower prevalence of low CS and hyperfibrinolysis based on EXTEM and FIBTEM results. The correlation of CS, FCS and CT versus equivalent ROTEM parameters was strong with r-values of 0.83, 0.79 and 0.79, respectively.
Discussion This first clinical experience with the Quantra in trauma patients showed that the QStat Cartridge was strongly correlated with ROTEM parameters and that it could detect coagulopathies associated with critical bleeding.
Level of evidence Diagnostic test, Level II.
- blood coagulation
- blood coagulation tests
- fibrinolysis
- hemorrhage
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Footnotes
Contributors EAM, MWC and BR: study design, data collection, data interpretation, writing of the manuscript and critical revision. DAW: literature search, study design, writing of the manuscript and critical revision. FV: literature search, data analysis, data interpretation and initial drafting of the manuscript.
Funding The study was funded by HemoSonics, LLC (Charlottesville, Virginia, USA).
Competing interests DAW and FV are employees of HemoSonics, LLC, a medical device company that is commercializing the Quantra QStat System.
Patient consent for publication Not required.
Ethics approval The study obtained approval from the Institutional Review Boards (IRB) at the Texas Tech University Health Sciences Center (IRB# E19021) and the UT Southwestern (IRB# STU-2018–0039). Through a deferred consent process, each participant or their legally authorized representative was approached to provide written informed consent to enable release of their data to the study database.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information. All data relevant to the study are included in the article.