A multicenter reference interval study of thromboelastography in the Chinese adult population.

BACKGROUND

Imprecise reference intervals (RIs) adversely impact the determination of the need for blood transfusion and clinical diagnosis and treatment of coagulopathy. However, there are few RI studies of thromboelastography (TEG) based on a standard protocol. The present multicenter study aimed to establish RIs for the adult Chinese population.

METHODS

Healthy participants were recruited from 6 medical centers by non-probability sampling. Blood samples were subjected to laboratory TEG analysis. The Ichihara method, 2-level nested analysis of variance (ANOVA) (2N-ANOVA), and the latent abnormal values exclusion (LAVE) were used to define the RIs following recommendations of the Clinical and Laboratory Standards Institute and International Federation of Clinical Chemistry and Laboratory Medicine, Committee on Reference Intervals and Decision Limits. Multiple regression analysis was performed to explore sources of variation.

RESULTS

A total of 507 healthy participants were enrolled into the study cohort. Twenty-five individuals with potential coagulopathy were secondarily excluded by LAVE. Smoking was related to reaction time, α angle, and coagulation index in the TEG test (P < 0.05). 2N-ANOVA revealed that the RIs of all 5 test items of TEG needed to be partitioned by age and sex. Finally, TEG RIs were derived both parametrically and nonparametrically for males or females and different age Groups, respectively.

CONCLUSIONS

TEG RIs were established for the adult Chinese population using up-to-date methodology. The results will provide a useful and essential comparator for patients in the assessment of coagulation state, goal-directed blood transfusion therapy, and monitoring of the pharmacodynamic effects of anticoagulant drugs.