Exploring the utility of a novel point‐of‐care whole blood thrombin generation assay following trauma: A pilot study

Abstract

Introduction Plasma thrombin generation kinetics as measured by the calibrated automated thrombogram (CAT) assay is a predictor of symptomatic venous thromboembolism after trauma. We hypothesized that data from a new prototype assay for measurement of thrombin generation kinetics in fresh whole blood (near patient testing of thrombin generation), will correlate with the standard CAT assay in the same patients, making it a potential tool in the future care of trauma patients. Methods Patients were enrolled from June 2018 to February 2020. Within 12 hours of injury, blood samples were collected simultaneously for both assays. Variables compared and correlated between assays were lag time, peak height, time to peak, and endogenous thrombin potential. Data are presented as median with interquartile range (IQR). Spearman and Pearson correlations were estimated and tested between both assays; a P value of <0.05 was considered to be significant. Results A total of 64 trauma patients had samples analyzed: injury severity score = 17 (IQR), 10‐26], hospital length of stay = 7.5 (IQR), 2‐18) days, age = 52 (IQR, 35‐63) years, 71.9% male, and 42.2% of patients received a transfusion within 24 hours of injury. Thrombin generation parameters between plasma and whole blood were compared and found that all parameters of the two assays correlate in trauma patients. Conclusion In this pilot study, we have found that a novel point‐of‐care whole blood thrombin generation assay yields results with modest but statistically significant correlations to those of a standard plasma thrombin generation assay. This finding supports studying this device in a larger, adequately powered study.

Direct oral anticoagulants or vitamin K antagonists in emergencies: comparison of management in an observational study

“…Another alternative is using global hemostatic assays, such as thrombin generation or a modified DOAC thromboelastogram, which are reported to be sensitive to low DOAC levels [ 40 , 41 ]. However, further work is needed in larger MH and UHR cohorts to explore whether the point-of-care thrombin generation [ 42 ] or modified thromboelastogram strategy would be helpful for DOAC emergency management. Recently, urine detection of the type of DOAC could assist in overcoming the uncertainty of which DOAC was taken in an unconscious patient.…”

Estradiol provokes hypercoagulability and affects fibrin biology: A mechanistic exploration of sex dimorphisms in coagulation

“…In addition, whole blood TG was performed after pretreatment of the blood with physiologic concentrations of betaestradiol (as described above) with the Stago WB TG device (Near Patient Testing TG [NPT-TG]). The device, which has been described and validated in previous studies, [10][11][12] functions by activating TG by relipidated tissue factor, after which point, the reaction is continuously monitored by means of a thrombin-specific fluorogenic substrate; change in fluorescence intensity produced by the cleavage of the fluorogenic substrate by thrombin is monitored over time and compared with an internal calibrator with known stable thrombin activity. Whole blood TG was initiated using 6.5 pM relipidated tissue factor reagent and 15 mM CaCl 2 (Stago, US), and TG curves were recorded continuously for 90 minutes at a rate of three readings per minute alongside an internal calibrator.…”

Point-of-Care Platform for Diagnosis of Venous Thrombosis by Simultaneous Detection of Thrombin Generation and D-Dimer in Human Plasma

“… 27 Two of these methods are based on fluorogenic assays with a scan time of 50–120 min, and third one is chromogenic assay with a scan time of 20 min. Although researchers have explored the possibility of developing a point-of-care TGA, 28 , 29 currently no device has been developed. There is an increasing need for a point-of-care device that can simultaneously detect D-dimer and TG.…”