paddu THESIS protocol submission for nbe

Thesis protocol

1. A STUDY OF HEMATOLOGICAL AND BLOOD COAGULATION PARAMETERS IN PATIENTS OF PULMONARY TUBERCULOSIS A research study by Dr P Padmanabhaiah DNB Resident 1 st year Department of General medicine District Hospital Chikkaballapur Guide Dr Thimmegowda H V M.D General Medicine Senior Consultant DNB Department of General Medicine District Hospital Chikkaballapur Co - Guide Dr Madhu Kumar M H M.D General Medicine Junior Consultant DNB Department of General Medicine District Hospital Chikkaballapur

2. Title – A STUDY OF HEMATOLOGICAL AND BLOOD COAGULATION PARAMETERS IN PATIENTS OF PULMONARY TUBERCULOSIS Duration of study – 18 months July 2023 to December 2024 Place of study – OPD and in patient wards of DH Chikkaballapur

3. Introduction Tuberculosis is a communicable disease that is a major estimated cause of ill health and one of the leading causes of death worldwide. An estimated global total of 10.6 million people fell ill with tb in 2021,equivalent to 134 cases per 100000 population.Among all tb cases,6.7%were among people living with hiv .

4. The pathogen responsible for this widespread and persistent infection is Mycobacterium Tuberculosis, which resides in macrophages,and induces the death of its host cells. Infection starts when inhaled bacilli are phagocytosed by alveolar macrophages. In response to this infection, immune cells produce some proinflammatory cytokines such as interleukin (il)-1, il-6, and tumor necrosis factor ( tnf )-α; affecting homeostasis

5. An increase in C-reactive protein (CRP) , due to increase in hepatic synthesis of acute phase proteins , and an increase in ESR follow the inflammatory process and hence these parameters are used in the diagnosis and follow-up patients . Under normal circumstances the coagulation system is balanced by adequate anti-coagulation. However, during such proinflammatory conditions, such as acute pneumonia and sepsis, derangement of anticoagulant mechanisms has been observed both in the lungs and systemically.

6. Diverse coagulation abnormalities have been reported in the setting of TB. These changes include increased procoagulant activity (prothrombin time (PT), activated partial thromboplastin time ( aPTT ), fibrinogen and D-dimer, decreased anticoagulant factors (antithrombin III, protein S, protein C,) suppress fibrinolysis resulting in hypercoagulable state

7. REVIEW OF LITERATURE: In a study conducted by Suryakusumah L, Tabri NA, Saleh S, et al ., 30 subjects are new cases of PTB. Prothrombin time, aPTT and D-dimer levels were higher in far advanced lesions and smear-positive sputum group (p<0.001). In a study conducted by Rohini K, Surekha Bhat M, Srikumar PS, et al The mean values for serum hemoglobin level, RBC count and platelet count in PTB was found to be less (by nearly 1.4-fold, 1.5-fold and 1.2-fold respectively) than that of normal controls and these differences were statistically significant (p < 0.001 for all).

8. Need for the study Diverse coagulation abnormalities have been reported in the setting of tuberculosis. The current protocols for the management of Pulmonary TB doesn’t give importance to coagulation profile. Considering the importance of the coagulation factors and the reported abnormalities in hemostatic parameters during TB infection, We thought it wise to evaluate coagulation parameters d- dimer , PT , INR , aPTT in patients with tuberculosis and their role in assessing response to anti tubercular treatment after intensive phase treatment.

9. AIM - to study haematalogical and blood coagulation parameters in patients of PTB. Objective - this study establishes tuberculosis infection and coaugalation changes in ptb patients before and after antituberculosis intensive therapy of att ( after 2 months ) To assess haematalogical parameters in patients with tuberculosis. ( Platelets, pt, aptt , inr , fibrinogen, d dimer) Study area - this study is carried out at District Hospital , chikkaballapur . Sample size - 50 ptb cases Study duration :12-18 months

10. Selection criteria INCLUSION CRITERIA CONFIRMED PTB PATIENTS, NON PREGNANT WOMEN, no record of any other chronic disease patients willing to take part in the study

11. EXCLUSION CRITERIA Patients with bleeding disorder Patients with endocrine disorder,or systemic disorders Patients with concomitant chronic infection

12. METHODS Methods - this study consist of case control study Sample of 50 ptb patients and 50 controls. Statistical methods - the information collected regarding all the selected cases will be recorded in a master chart, data analysis will be done with the help of computer using epidemiological information package. Using the software,range,frequiencies,percentages,means,standard deviations,chi square,and p values will be calculated,

13. THANK YOU