Reference Intervals for ROTEM-tPA: Whole-Blood Fibrinolysis Assessment in Healthy Adults

Area of Science:

• Hemostasis and Thrombosis
• Clinical Diagnostics
• Laboratory Medicine

Background:

• Fibrinolysis is crucial for hemostatic balance; its dysregulation leads to bleeding and thrombotic disorders.
• Rotational thromboelastometry modified with tissue plasminogen activator (ROTEM-tPA) assesses fibrinolytic capacity but lacks reference intervals in healthy individuals.
• Standardized interpretation and clinical implementation of ROTEM-tPA are hindered by the absence of established reference values.

Purpose of the Study:

• To establish comprehensive reference intervals for ROTEM-tPA parameters in a healthy adult population.
• To provide a foundation for standardized interpretation of fibrinolytic dynamics.
• To support the clinical application of ROTEM-tPA in managing bleeding and thrombotic disorders.

Main Methods:

• Analyzed citrated whole blood samples from 122 healthy plasma donors (aged 20-69 years, equal sex distribution).
• Utilized a standardized ROTEM-tPA protocol with exogenous tissue plasminogen activator (tPA) activation (125 ng/mL).
• Calculated reference intervals using a non-parametric approach with 90% confidence intervals (CLSI EP28-A3c guidelines).

Main Results:

• Established reference intervals for all ROTEM-tPA parameters, demonstrating consistent performance across age and sex.
• High analytical repeatability was observed, indicated by low coefficients of variation.
• Key parameter reference intervals include: clotting time (45-68 s), lysis index at 30 min (0-97%), and lysis time (1412-3211 s).

Conclusions:

• The first comprehensive reference intervals for ROTEM-tPA in healthy adults have been established.
• These reference intervals facilitate standardized interpretation of fibrinolytic function.
• The findings support the clinical utility of ROTEM-tPA for diagnosing and managing hemostatic disorders.