Evaluation of Prothrombin Time, International Normalized Ratio and Activated Partial Thromboplastin Time Tests In Diabetes Mellitus Patients At Meru Teaching And Referral Hospital In Kenya

Abstract

Diabetes mellitus (DM) is one of the non-communicable diseases (NCDs) leading to disease burden in Kenya. Diabetics have an increased risk of developing complications such as thrombosis if proper care is not taken to those with the disease as a result of hyperglycemia. Many cases may not be detected as many health facilities do not screen for hyperglycemia. This study was done to evaluate the effect of hyperglycemia on coagulation mechanism since no study has been done on this. The study focused on evaluating the effects of hyperglycemia on prothrombin time (PT), international normalized ration (INR) and activated partial thromboplastin time (aPTT) in relation to sex, age and duration of illness in DM patients attending Meru Teaching and Referral Hospital. Ethical clearance was sought from Ethics and Research Committee of KNH/UoN ERC and research permit from National Commission for Science, Technology and Innovation (NACOSTI). A case control study, employing random systematic sampling method to recruit participants in the outpatient diabetic clinic in Meru Teaching and Referral Hospital was done from June 2019 to October 2019. 371 diabetic cases and 371 healthy controls aged 18-60 years and below were recruited upon meeting the inclusion criteria and upon consenting. Recruitment to the study was done with an aid of structured questionnaire. Coagulation parameters (PT, INR and aPTT) were analyzed directly with coagulation analyzer (Start4) while blood glucose parameters were analyzed at the point of contact with on call plus glucometer. The results were entered to MS-excel and uploaded to SPSS software package version 23 and computed statistically. Demographics attributes of study participants were expressed in percentage. Mean and standard deviation were used to express results. Linear regression was used to determine the relationship of coagulation parameters diabetic cases and those of controls. Comparison between coagulation parameters and duration of illness was done by use of analysis of variance (One way-ANOVA) while comparison of coagulation parameters according to sex was done by using independent-sample t test. Variation of coagulation parameters in diabetic participants in relation to age was done using one-way ANOVA, followed by Tukey Post HOC Test. Results revealed that (diabetic group) the male subjects were 152 (41%) and female subjects were 219 (59%) while in the healthy group, the males were 157 (42.3%) and females were 214 (57.7%). Prothrombin time was 12.726±1.307 seconds and 12.487±1.016 seconds in the diabetic subjects and normal group respectively (p=0.215). The International normalized ratio was 1.0142±0.137 and 0.9891±0.102 in diabetic participants and normal group respectively (p=0.221). There was no statistically significant difference (p=0.05) between the Prothrombin time and International normalized ration means of diabetic subjects and the normal group in relation to duration of illness, age and sex of the participants. The activated partial thromboplastin time (aPTT) was 30.656±3.74 seconds and 34.424±2.71 seconds in the diabetics and normal group respectively (p=0.445). Sex, and duration of illness did not have significant effect (p=0.564 and p=0.887 respectively) on the aPTT, but age had significant effect in different age groups in diabetic participants (p=0.005). In conclusion, the findings of this current study is that; PT, INR and aPTT were not significantly different in normal group as compared to diabetes mellitus group. It is recommended that a study be done on both treated and untreated diabetics to determine if there is a significant difference in coagulation status between the two groups.