Establishing reference ranges and normal values for coagulation screening in healthy Indian male volunteers enrolled for a longitudinal study

Abstract

Background: The study was designed for establishing reference ranges and normal values for coagulation screening in healthy Indian male volunteers. At present, there are no standard parameters established for coagulation screening assays of Indian population. The parameters used as a reference in the coagulation assays are of Western origin. We know that ethnicity of the western population is different from the Indian population which may result in a different set of reference ranges of the coagulation assay. It is necessary to determine the mean normal values for the coagulation assay, namely prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), and fibrinogen in an Indian population. The aim of the study was to establish the reference ranges of coagulation assays for all future experiments on the cohort. Methods: Six hundred healthy male volunteers were sampled and underwent coagulation testing at a seven hundred-bedded hospital at Jammu (Jammu). Fresh normal pool plasma (FNPP) was prepared concurrently and investigated (n = 50 volunteers). In the study population, the arithmetic means of the coagulation assay were as follows: PT: 13.00 s, APTT: 34 s, TT: 17.3 s, and fibrinogen: 298 mg/dl (19 s), and in the FNPP, it was 12.8 s, 33.2 s, 17 s, and 298 mg/dl (19 s), respectively. Results: The reference range of coagulation screening in our study was established as the following values: PT: 10.7–15.3 s, APTT: 26.8–41.2 s, TT: 12.8–21.7 s, and fibrinogen: 223–372 mg/dl. This study has set a reference range of normal values for coagulation assay screening in longitudinal studies where these tests were repeated on the same set of individuals at six-month interval for the subsequent 3 years. Conclusion: We see no effect of age on Coagulation cascade in our study. Overall mean values resembled with various age groups in coagulation cascade. These parameters of Coagulation cascade set a standard for high altitude studies where these tests are in normal procedure.

Keywords

• Activated partial thromboplastin time
• coagulation
• fibrinogen
• prothrombin time
• thrombin time