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CTRI Number  CTRI/2012/12/003271 [Registered on: 31/12/2012] Trial Registered Retrospectively
Last Modified On: 01/03/2013
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   DESCRIPTIVE-CORRELATIVE STUDY 
Study Design  Other 
Public Title of Study   A CLINICAL STUDY OF SEVERITY(COMPLICATIONS) OF DIFFERENT TYPES OF MALARIA 
Scientific Title of Study   SPLENOMEGALY AND THROMBOCYTOPENIA - IN CORRELATION WITH THE TYPE AND SEVERITY IN MALARIA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DEEPAK CL 
Designation  PG RESIDENT 
Affiliation  FATHER MULLER MEDICAL COLLEGE 
Address  DEPARTMENT OF GENERAL MEDICINE, FATHER MULLER MEDICAL COLLEGE, KANKANADY, MANGALORE, KARNATAKA, INDIA.

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9916207061  
Fax    
Email  dr_deepakcl@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  DR SMITHA BHAT 
Designation  PROFESSOR 
Affiliation  FATHER MULLER MEDICAL COLLEGE 
Address  DEPARTMENT OF GENERAL MEDICINE, FATHER MULLER MEDICAL COLLEGE, KANKANADY, MANGALORE, KARNATAKA, INDIA.

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845162167  
Fax    
Email  doctorsmitha@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DEEPAK CL 
Designation  PG RESIDENT 
Affiliation  FATHER MULLER MEDICAL COLLEGE 
Address  DEPARTMENT OF GENERAL MEDICINE, FATHER MULLER MEDICAL COLLEGE, KANKANADY, MANGALORE, KARNATAKA, INDIA.

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9916207061  
Fax    
Email  dr_deepakcl@yahoo.co.in  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  DEEPAK CL 
Address  DEPARTMENT OF GENERAL MEDICINE, FATHER MULLER MEDICAL COLLEGE, KANKANADY, MANGALORE, 
Type of Sponsor  Other [DEEPAK CL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DEEPAK CL  FATHER MULLER MEDICAL COLLEGE HOSPITAL  DEPT OF GENERAL MEDICINE, 4TH FLOOR, FATHER MULLER MEDICAL COLLEGE HOSPITAL, FATHER MULLER ROAD, KANKANADY, MANGALORE- 575002
Dakshina Kannada
KARNATAKA 
9916207061

dr_deepakcl@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Malaria,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients in the age group of 18-60 years admitted with smear positive for falciparum/vivax malaria in Father Muller Medical College Hospital will be included in the study. 
 
ExclusionCriteria 
Details  •Patients with a clinical features and/or diagnosis of associated dengue fever, leptospirosis and typhoid fever.
•Patients with immunocompromised status or receiving immunosuppressive treatment.
•Chronic liver disease.
•Pregnant women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To find whether thrombocytopenia can be used as an early indicator of severity in malaria.
2.To find the association between degree of thrombocytopenia and splenomegaly in malaria.
3.To correlate thrombocytopenia and splenomegaly with type and severity in malaria.
 
Single time point at the end of the study 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/10/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Malaria is a common communicable disease and is a major public health problem in India, resulting in high morbidity and mortality. Splenomegaly and thrombocytopenia are common findings in malaria. Thrombocytopenia is present in 80% of the patients with malaria and some studies show that thrombocytopenia in malaria closely correlates with the degree of parasitemia. However, thrombocytopenia is not included in the WHO criteria for severe malaria. This study aims to find whether thrombocytopenia can be an indicator of severe malaria as it is a hematological parameter that is present even before other features of severe malaria set in. It also aims to find the association between degree of thrombocytopenia and splenomegaly in malaria.

Severe malaria is defined according to the WHO guidelines. The presence of one or more of the following clinical or laboratory features classifies the adult patient as suffering from severe malaria. Clinical features like a) impaired consciousness or unrousable coma, b) prostration (generalized weakness so that the patient is unable to walk or sit up without assistance), c) multiple convulsions (>2 episodes in 24hours), d) deep breathing, respiratory distress (acidotic breathing), e) circulatory collapse or shock (systolic BP <70mmHg), f) clinical jaundice plus evidence of other vital organ dysfunction, g) hemoglobinuria, h) abnormal spontaneous bleeding, i) pulmonary edema (radiological). Laboratory findings like a) hypoglycemia (blood glucose <40mg/dl), b) metabolic acidosis (plasma bicarbonate <15mmol/l), c) normocytic anemia (Hb <5g/dl, packed cell volume <15%), d) hemoglobinuria, e) hyperlactataemia (lactate >5mmol/l), f) renal impairment (serum creatinine >3mg/dl), g) hyperparasitemia (2%/100,000/μl in low intensity transmission areas or >5% or 250,000/μl in high intensity transmission areas).

Thrombocytopenia by definition is an abnormally low amount of platelets, less than 1,50,000 per microliter of blood.

 
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