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Rajiv Gandhi University Of Health Sciences, Karnataka

Bangalore.
Annexure- II

Proforma For Registration Of Subjects For Dissertation



1.


NAME OF THE CANDIDATE AND ADDRESS

(IN BLOCK LETTERS)



DR LIJO JAMES

PUTHIYAPARAMBIL HOUSE

MANTHURUTHY P.O NEDUMKUNNAM,

KOTTAYAM , KERALA , 686542


2.


NAME OF THE INSTITUTION


KARNATAKA INSTITUTE OF

MEDICAL SCIENCES, HUBLI-22.



3.


COURSE OF STUDY AND SUBJECT


M.D. IN GENERAL MEDICINE.



4.


DATE OF ADMISSION TO COURSE


31-05-2012



5.


TITLE OF THE TOPIC


A STUDY OF CLINICAL AND IMAGING PROFILE IN SPONTANEOUS INTRACEREBRAL HEMORRHAGE


6.


brief resume of the intended work:

6.1 NEED FOR STUDY. Cerebrovascular diseases rank first in frequency and importance

among all neurologic diseases. Of all the cerebrovascular diseases, intracerebral

haemorrhage is the most dramatic and catastrophic. Various clinical and radiological

parameters have been proved useful as predictors of prognosis in spontaneous

intracerebral hemorrhage . This study is to identify the risk factors, correlate various

clinical and radiological parameters with the prognosis of the patients and to

assess the utility of Intracerebral Hemorrhage(ICH) score in intracerebral

hemorrhage in patients attending KIMS hospital Hubli




6.2 REVIEW OF THE LITERATURE:

Stroke is the second leading cause of death worldwide, and one of the leading causes of disability. With increasing life expectancy the burden of stroke is likely to increase worldwide with middle and low income countries particularly affected. Intracerebral hemorrhage is the second most

common subtype of stroke after ischemic stroke and accounts for approximately 10 % to 20 % of all strokes. Hypertension has been identified as the single most important risk factor causing intracerebral hemorrhage. Other risk factors include alcohol, smoking, diabetes, anticoagulant use1and other genetic risk factors. The incidence of intracerebral hemorrhage increases with age and it is more among men and in Asians 1.
Nag C, Das K, Ghosh M, Khandakar M R3 concluded in their study that in primary intracerebral hemorrhage, from a single non contrast CT scan, clinical outcome can be assessed on admission by using the CT scan parameters like hematoma volume, location of stroke, midline shift , intraventricular extension of bleed and ventricle compression. Mansooreh togha and Khadigeh Bakhtavar4 in their study concluded that factors independently associated with in-hospital mortality were Glasgow Coma Scale (GCS) score (≤ 8), diabetes mellitus disease, volume of hematoma and intraventricular hematoma and that higher rate of mortality were observed during the first two weeks of hospitalization following ICH. Ak. Joy Singh, Kh. Mani Singh Ak. Brogen , W Jatishwor Singh, N Bimol Singh5 concluded in their study that death and functional outcome on 30th day were well correlated with the initial volume of bleed .

Hemphill JC, Bonovich DC ,Besmertis L, Manley GT, Johnston SC6 proved in their study the ICH score is a simple clinical grading scale that allows risk stratification on presentation with ICH. The use of a scale such as the ICH Score could improve standardization of clinical treatment protocols and clinical research studies in ICH. Daniel Agustin Godoy, Gustavo Pinero Mario Di Napoli7 confirmed in their study that, the ICH score is a good predictor of 30-mortality and functional outcome in different socioeconomic population.



6.3 AIMS AND OBJECTIVES OF THE STUDY:



  • 1. To study the clinical profile of spontaneous intracerebral hemorrhage and to identify the risk factors.




  • 2. To study the clinical and radiological parameters that would predict the prognosis of hemorrhagic stroke.




  • 3. To assess the utility of ICH score as a tool to predict outcome of hemorrhagic stroke.





7.


MATERIALS AND METHODS :

7.1 SOURCE OF DATA: All patients admitted in Department of Medicine, Karnataka Institute

of Medical Sciences, Hubli during the period of 1st November 2012 to 31st October 2013 will

be taken for study considering the inclusion and exclusion criteria .
7.2 METHODS OF COLLECTION OF DATA:

Information will be collected through prepared proforma for each patient.



  • All patients will be interviewed as per the proforma and a complete clinical examination will be done.

  • Cases of spontaneous intra cerebral hemorrhage diagnosed with clinical history, examination and non-contrast CT.

  • Patients’ demographic, social, economic and medical details will be

recorded in the proforma sheet.

The following data are to be collected from the patients.

1. Age.

2. Temperature in °F at admission.



3. Mean arterial pressure. This is calculated by:

Mean arterial pressure = Diastolic pressure + 1/3 pulse pressure

4. Glasgow coma score at admission.

CT brain will be done on the day of admission and the following data

will be collected.

5. Volume of Bleed.

6. Location of Bleed.

7. Presence / absence of intraventricular haemorrhage, midline shift,

hydrocephalus.

Results will be analysed with appropriate statistical methods.


SAMPLE SIZE:

As per hospital statistics 33 patients were patients were admitted in Department of Medicine, KIMS, Hubli in the year 2011 with spontaneous intracerebral hemorrhage. All the patients admitted with spontaneous intracerebral hemorrhage in medical wards during the period will be taken for the study.


TYPE OF STUDY: Follow up study(30days), hospital based, time bound study.
SAMPLING: All the patients presenting with spontaneous intracerebral hemorrhage in

Medicine Department, KIMS Hospital during this period will be taken for the study.


Inclusion criteria :

All patients >18yrs admitted with spontaneous intracerebral hemorrhage to

medical wards of KIMS, Hubli.
Exclusion criteria:

1. Traumatic Intracerebral hemorrhage.

2. Hemorrhagic infarct.

3. Infective, metastatic etiology.

4. Primary intraventricular hemorrhage.

5. Hemorrhagic disorders.

6. Aneurysms, Arteriovenous malformations.

7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? (If so, please describe briefly) - YES

1. Routine investigations- RBS, Blood Urea, Serum Creatinine, Blood Grouping and Rh

typing, HIV, HBsAg.

2. Complete Haemogram.

3. Non contrast CT.
7.4 Has ethical clearance been obtained from ethical committee of your institution in case of

7.3? - YES

Ethical clearance has been obtained from the ethical committee KIMS, Hubli. A copy has

been enclosed.



8.


List of References:

1. M.arfan Ikram MD, Renske G Wieberdink MD, Peter J Koudstaal International

epidemiology of Intracerebral hemorrhage . Current Atherosclerosis reports

Aug14(4) 2012, 300-306.



2. Van Asch CJ,Luitse MJ, Rinkel GJ,Van der Tweel ,Algra A ,Klijn CJ Incidence,

case fatality, and functional outcome of intracerebral haemorrhage over

time, according to age, sex, and ethnic origin: a systematic review and

meta-analysis. Lancet ,2010 Feb;9(2):167-76.

3. Nag c , Das K ,Ghosh M ,Khandakar MR Prediction of Clinical Outcome in Acute

Hemorrhagic Stroke from a Single CT Scan on Admission

North American journal of Medical Sciences 2012 Oct; 4(10):463-7.

4. Mansooreh Togha and Khadigeh Bakhtavar. Factors associated with in-hospital

mortality following intracerebral hemorrhage: a three year study in Tehran,

Iran. BMC Neurol. 2004; 4: 9.


5. Joy Singh, Mani Singh et al. CT Scan as a Tool for Predicting Outcome of Stroke

due to Intracerebral Haemorrhage at a Referral Hospital.

IJPMR October 2006; 17 (2): 33-38.


6. Hemphill JC III, Bonovich DC, Besmertis L, Manley GT, Johnston SC. The ICH

score: a simple, reliable grading scale for intracerebral hemorrhage.

Stroke.2001; 32: 891–897.

7. Daniel Agustin Godoy MD, Gustavo Pinero MD,Mario Di Napoli MD Predicting

mortality in Intracerebral hemorrhage ,Stroke, 2006 ,37,1038-1044.

8. Edward Feldmann, MD; Joseph P. Broderick, MD; Walter N. Kernan, MD .Major



Risk Factors for Intracerebral Hemorrhage in the Young Are Modifiable.

Stroke.2005; 36: 1881-1888.







9.

SIGNATURE OF THE CANDIDATE







10.

REMARKS OF THE GUIDE






11.

NAME AND DESIGNATION


11.1 GUIDE




Dr. H. MALLIKARJU N SWAMY.

PROFESSOR AND HEAD

DEPARTMENT OF MEDICINE

KIMS, HUBLI.




11.2 SIGNATURE






11.3 CO-GUIDE





11.4 SIGNATURE




11.5 HEAD OF THE

DEPARTMENT





Dr. H. MALLIKARJUN SWAMY.

PROFESSOR AND HEAD

DEPARTMENT OF MEDICINE

KIMS, HUBLI.



11.6 SIGNATURE



12.


12.1 REMARKS OF THE

PRINCIPAL AND



CHAIRMAN





12.2 SIGNATURE





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