Thrombin generation measured by two platforms in patients with a bleeding tendency

Area of Science:

• Hematology
• Hemostasis and Thrombosis

Background:

• Mild to moderate bleeding disorders present diagnostic challenges, often remaining undiagnosed despite extensive laboratory testing.
• Thrombin generation (TG) assays offer a comprehensive measure of hemostatic system functionality.
• TG may serve as a valuable tool for identifying patients with a bleeding tendency.

Purpose of the Study:

• To evaluate the additional diagnostic value of TG in patients with mild bleeding tendencies.
• To assess TG's utility in patients with and without a diagnosis after conventional laboratory testing.
• To investigate the impact of different result expressions, inter-method variability, and reference ranges on TG analysis.

Main Methods:

• Thrombin generation was measured using two platforms: ST Genesia and calibrated automated thrombogram (CAT).
• Patient and control data were statistically analyzed (Mann-Whitney U tests) and visualized using box-and-whisker plots.
• Results were normalized or corrected, and reference intervals were established; reagent lot-to-lot variability was also assessed.

Main Results:

• Abnormal TG parameters were detected in 62.7% (ST Genesia) to 69.5% (CAT) of patients initially undiagnosed by traditional methods.
• Previously diagnosed patients also showed abnormal TG parameters in 58.1% of cases for both assays.
• No significant lot-to-lot reagent variability was observed for either platform.

Conclusions:

• Incorporating TG assays can significantly improve the diagnosis of mild bleeding disorders.
• TG demonstrates potential as a diagnostic tool for bleeding tendencies, warranting further investigation before widespread clinical adoption.