Coagulation parameters reference interval for adult population of Debre Berhan town, Northeast Ethiopia

Abstract

BACKGROUND: Accurate coagulation parameter reference intervals are crucial for diagnosing bleeding disorders and thromboembolic diseases. However, reference intervals vary across populations due to genetic, environmental, and demographic factors. This study aimed to establish localized coagulation reference intervals for healthy adults of Debre Berhan, Northeast Ethiopia, addressing the current reliance on non-local values. METHODS: A community-based cross-sectional study was conducted in Debre Berhan, Northeast Ethiopia, from October-December 2024. We recruited 240 healthy adults (120 of each gender) using convenience sampling. Participants were interviewed face-to-face using a pre-tested questionnaire on KoBoToolbox to collect demographic data. Aseptically drawn venous blood was analyzed for coagulation parameters using Sysmex CA-104 coagulation analyzer. Stata 17 was used for data analysis, with reference intervals determined by the 2.5th and 97.5th percentiles. Gender differences were assessed using the Mann-Whitney U test (p < 0.05 significance). RESULTS: The established 95% coagulation reference intervals (2.5th -97.5th percentile) were: Prothrombin time (8.5-13.0 sec), international normalized ratio (0.7-1.1), and activated partial thromboplastin time (21.6-37.9 sec). Males exhibited significantly higher median PT (10.4 Vs. 9.8 sec, p = 0.0006) and INR (0.9 Vs. 0.84, p = 0.0006) values compared to females. CONCLUSION: This study's findings strongly support the adoption of population-specific reference intervals to ensure accurate diagnoses and improve patient safety within the Debre Berhan adult population. The observed gender-related differences in Prothrombin time and international normalized ratio values further highlight the need for gender-specific reference intervals to improve clinical decision-making and prevent potential misinterpretations of coagulation test results.