Establishment of reference intervals and transfusion criterion for Sonoclot analysis

Area of Science:

• Hematology
• Clinical Chemistry
• Medical Devices

Background:

• The Sonoclot analyzer is widely used globally for coagulation monitoring.
• Manufacturer-provided reference intervals are based on a small sample size (45 participants).
• No established transfusion cut-off values exist for Sonoclot analysis.

Purpose of the Study:

• To establish reliable reference intervals for Sonoclot analysis in Chinese adults.
• To determine transfusion criteria for Sonoclot analysis in Chinese patients.
• To assess the suitability of manufacturer reference intervals for the Chinese population.

Main Methods:

• Recruited 135 healthy Chinese adults and 281 cardiac surgery patients.
• Measured activated clotting time (ACT), clot rate (CR), and platelet function (PF) using Sonoclot.
• Determined reference intervals via nonparametric methods and transfusion cut-offs using ROC curves.

Main Results:

• Established 95% reference intervals: ACT 96-195 s, CR 22-51 U/min, PF >1.6.
• Determined transfusion cut-off values: ACT >208 s, CR ≤14 U/min, PF ≤1.3.
• Found manufacturer reference intervals were not suitable for Chinese participants.

Conclusions:

• The established reference intervals and transfusion criteria are specific to the Chinese population.
• These findings will aid in more accurate Sonoclot analysis interpretation for Chinese patients.
• Recommends using study-derived values over manufacturer intervals for Chinese populations.