Thesis protocol

1. A STUDY OF HEMATOLOGICALAND BLOOD
COAGULATION PARAMETERS IN PATIENTS OF
PULMONARY TUBERCULOSIS
A research study by
Dr P Padmanabhaiah
DNB Resident 1st 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