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CTRI Number  CTRI/2020/07/026640 [Registered on: 17/07/2020] Trial Registered Prospectively
Last Modified On: 17/07/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Testing for leptospirosis infection in healthy donors 
Scientific Title of Study   A pilot study on screening of blood donors for emerging transfusion transmissible Leptospirosis infection in an endemic area. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepika Chenna 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Immunohematology and Blood Transfusion, KMC, Manipal

Udupi
KARNATAKA
576104
India 
Phone  09901470899  
Fax    
Email  deepu.kkd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shamee Shastry 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Immunohematology and Blood Transfusion, KMC, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9743489837  
Fax    
Email  shameeshastry@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deepika Chenna 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Immunohematology and Blood Transfusion, KMC, Manipal

Udupi
KARNATAKA
576104
India 
Phone  09901470899  
Fax    
Email  deepu.kkd@gmail.com  
 
Source of Monetary or Material Support  
J. mitra & Company Pvt Ltd A-180-181 Okhla Industrial Area Phase 1 New Delhi 110020 India  
 
Primary Sponsor  
Name  Directorate of Research Manipal Academy of Higher Education 
Address  Manipal Academy of Higher Education 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Deepika Chenna  Katurba Hospital  Blood Bank, Basement of trauma Triage
Udupi
KARNATAKA 
09901470899

deepu.kkd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kassturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Voluntary Blood Donors 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Blood donors who are residents of Udupi district only will be included.  
 
ExclusionCriteria 
Details  Blood donors form other districts will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The prevalence of leptospirosis infection would be studied, and the need for implementation of screening test for blood components.   March 30 2020 
 
Secondary Outcome  
Outcome  TimePoints 
the need for larger studies to evaluate the necessity of implementation of screening test for blood components.   December 31 2020 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   24/07/2020 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIl 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Emerging infectious diseases pose threats to the general human population, including recipients of blood transfusions. The risk of transmission of infection by blood transfusion results from collecting of blood from an infected donor while he is asymptomatic and the pathogen is present in his blood. The microbiological safety of the blood supply is continuously improving. The major focus has been HIV, hepatitis viruses and bacterial contamination. In fact, there are many infectious agents that are known, or that have properties that would predict the ability, to be transmissible by blood transfusion. A recent publication listed some 68 infectious agents with this characteristic, but for which interventions have not been implemented. [1] Leptospirosis is among such infections and is endemic in Karnataka and Kerala and we have outbreaks of Leptospirosis almost every year. The present study is planned to assess the need for implementation of newer donor screening strategies for detection of leptospirosis infection at our place. A prospective pilot study enrolling 500 healthy voluntary blood donors will be done. The donor sample will be collected after blood donation from the blood bag for screening of transfusion transmissible infections (HIV, HBV, HCV, Malaria and Syphilis). In addition to these mandatory screening tests we will be screening the sample for Leptospirosis infection by detection of leptospira specific Ig M antibodies by ELISA method. If a donor is found to be reactive, a confirmatory test would be performed by rapid kits and donor notification and the components prepared will be discarded

 
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