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CTRI Number  CTRI/2023/02/050071 [Registered on: 24/02/2023] Trial Registered Prospectively
Last Modified On: 23/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of Pre and Post donation changes in Serum Calcium, Magnesium, Sodium and Potassium levels in Platelet collection donors  
Scientific Title of Study   Modulation in Serum Cation level of Pre and Post Plateletpheresis among donors  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swathi 
Designation  Post graduation Student  
Affiliation  Manipal College of Health Profession  
Address  Department of Medical laboratory Technology Manipal College of Health Profession Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  6361325421  
Fax    
Email  swathi.mcoahsma10@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Saritha Kamath U 
Designation  Associate Professor and HOD Department of Medical laboratory Technology 
Affiliation  Manipal College of Health Profession  
Address  Department of Medical laboratory Technology, Manipal College of Health Profession Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9844344459  
Fax    
Email  saritha.kamath@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Saritha Kamath U  
Designation  Associate Professor and HOD Department of Medical laboratory Technology  
Affiliation  Manipal College of Health Profession  
Address  Department of Medical laboratory Technology, Manipal College of Health Profession Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9844344459  
Fax    
Email  saritha.kamath@manipal.edu  
 
Source of Monetary or Material Support  
Institutional seed money Department of Medical laboratory Technology Manipal College of Health Profession Manipal Academy of Higher Education Manipal  
 
Primary Sponsor  
Name  Institutional Seed money  
Address  Department of Medical laboratory Technology, Manipal College of Health Profession, Manipal Academy of Higher Education, Manipal  
Type of Sponsor  Other [Manipal College of Health Profession, Manipal Academy of Higher Education, Manipal ] 
 
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 
Swathi   Kasturba Hospital Manipal  Department of Immunohaematology and Transfusion medicine Kasturba Hospital Manipal Department of Medical laboratory Technology Manipal College of Health Profession Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA 		 6361325421

swathi.mcoahsma10@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba 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  Healthy volunteers who are donating blood cells 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable   Not Applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Healthy donors both male and female with age range 18-65 years
Pre apheresis platelet count greater than equal to 150000/L
Hemoglobin level greater than 12.5g/dL
Donor body weight greater than equal to 60 kg 
 
ExclusionCriteria 
Details  Donor with High blood pressure/ Diabetes mellitus/ Cardiac issues or an any drugs
Donors who are reactive to the Transfusion Transmitted infections 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Donors demographic detail and risk factors
Complete blood count
Calcium:mg/dl
Magnesium:mg/dl
Sodium:mEq/Lt
Potassium:mEq/Lt 		 6 month  
 
Secondary Outcome  
Outcome  TimePoints 
Variation in Complete blood picture  6 month  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   27/02/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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)?  

Response - NO
Brief Summary  
  • Informed written consent will be collected from donor who is registered for plateletpheresis.
  • Blood samples will be collected in EDTA and plain vccutainer from sterile diversion pouch placed on apheresis circuit before starting and after the procedure for complete blood count and biochemical parameters.
  •  During the procedure, 250 mg of calcium tablet is given to the donor as a part of standard of care.
  •  Demographic and risk factors details will be collected from the donors and samples were analysed for the required parameter as per the proforma.
  •  Complete blood picture will be done using semi autoanalyser using EDTA sample.
  •  Plain samples are centrifuged, serum will be used for measurement of Calcium, Magnesium, by kit method and Sodium and Potassium levels using flame photometer.
 
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