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CTRI Number  CTRI/2021/03/032323 [Registered on: 26/03/2021] Trial Registered Prospectively
Last Modified On: 25/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   An observational study about the clinical profile of Hemophagocytic Lymphohistiocytosis(a disease in which own immune cells eat up blood cells resulting in fall of blood cells) in children less than 12 years and about markers that decide good and bad prognosis of the disease. 
Scientific Title of Study   Clinical, Epidemiological and Hematological profile of Hemophagocytic Lymphohistiocytosis in Children less than 12 years and Rate of decline of Ferritin as a prognostic marker for disease outcome. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aishvarya R 
Designation  MD Resident of Pediatrics 
Affiliation  Institute of Child Health and Hospital for Children, Madras Medical College 
Address  Institute of Child Health and Hospital for Children, Madras Medical College,Tamil Saalai,Egmore.

Chennai
TAMIL NADU
600008
India 
Phone  9626478975  
Fax    
Email  aishvarya1396@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr S Lakshmi 
Designation  Professor,Department of Pediatrics,M3 unit 
Affiliation  Institute of Child Health and Hospital for Children, Madras Medical College 
Address  Tamil Saalai,Egmore

Chennai
TAMIL NADU
600008
India 
Phone  9840786852  
Fax    
Email  lakshmivel67@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Prof Dr S Lakshmi 
Designation  Professor,Department of Pediatrics,M3 unit 
Affiliation  Institute of Child Health and Hospital for Children, Madras Medical College 
Address  Tamil Saalai,Egmore

Chennai
TAMIL NADU
600008
India 
Phone  9840786852  
Fax    
Email  lakshmivel67@yahoo.co.in  
 
Source of Monetary or Material Support  
Institute of Child Health and Hospital for Children 
 
Primary Sponsor  
Name  None 
Address  None 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aishvarya R  M3 Unit,E Block(6th Floor),Dept-Pediatrics,Institute of Child Health and Hospital for Children,MMC  Tamil Saalai,Egmore, Chennai 600008
Chennai
TAMIL NADU 		 9626478975

aishvarya1396@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Madras Medical College, Chennai 600003  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D761||Hemophagocytic lymphohistiocytosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children less than 12yrs fulfilling criteria of Hemophagocytic lymphohistiocytosis.
1.A molecular diagnosis consistent with HLH (e.g., PRF mutations, SAP mutations) or
2. Presence of 5 of the following 8 symptoms, signs, or laboratory abnormalities:
a. Fever
b. Splenomegaly
c. Cytopenia (affecting ≥2 cell lineages; hemoglobin ≤9 g/dL [or ≤10 g/dL for infants <4 wk old], platelets <100,000/μL, neutrophils <1,000/μL)
d. Hypertriglyceridemia (≥265 mg/dL) and/or hypofibrinogenemia (≤150 mg/dL)
e. Hemophagocytosis in the bone marrow, spleen, or lymph nodes without evidence of malignancy
f. Low or absent natural killer cell cytotoxicity
g. Hyperferritinemia (≥500 ng/mL)
h. Elevated soluble CD25 (interleukin-2Rα chain; ≥2,400 U/mL) 
 
ExclusionCriteria 
Details  Macrophage Activation Syndrome (MAS) associated with Autoimmune disease
1.Systemic-onset juvenile idiopathic arthritis 2.Systemic lupus erythematosus
3.Enthesitis-related arthritis
4.Inflammatory bowel disease 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical, Epidemiological and Hematological profile of Hemophagocytic lymphohistiocytosis in children less than 12 years in a tertiary health center  Assessment of Participants from the time of admission for the entire period of hospital stay 
 
Secondary Outcome  
Outcome  TimePoints 
Rate of fall of ferritin as a prognostic marker  Every 5 days once S.Ferritin will be repeated until normalises 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/03/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Hemophagocytic lymphohistiocytosis is a life threatening disease associated with rapid clinical deterioration  often requiring intensive care treatment.Children under 12 years fulfilling the HLH criteria are included in study.This study is  to identify clinical parameters related to mortality and prognostic factors correlated with favourable/unfavorable outcome with main emphasis on S.ferritin ,which will be repeated every 5 days once until normalisation, as secondary outcome. 
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