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CTRI Number  CTRI/2020/10/028311 [Registered on: 09/10/2020] Trial Registered Prospectively
Last Modified On: 24/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Analysis of adverse events in voluntary platelet donors.  
Scientific Title of Study   Analysis of immediate and delayed adverse events in voluntary platelet donors associated with plateletpheresis procedure. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
3558  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priti Desai 
Designation  Professor 
Affiliation  Tata Memorial Hospital, HBNI 
Address  Department of Transfusion Medcine, Service block, 6th floor, Tata Memorial Hospital, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9987815691  
Fax  -  
Email  dr_priti99@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priti Desai 
Designation  Professor 
Affiliation  Tata Memorial Hospital, HBNI 
Address  Department of Transfusion Medcine, Service block, 6th floor, Tata Memorial Hospital, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9987815691  
Fax  -  
Email  dr_priti99@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pallavi Gaikwad 
Designation  Junior Resident 
Affiliation  Tata Memorial Hospital, HBNI 
Address  Service block, 6th floor, Tata Memorial Hospital, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  8999411865  
Fax    
Email  pallavi3832@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Department of Transfusion Medicine, Tata Memorial Hospital, Parel, Mumbai 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Priti Desai  Tata Memorial Hospital  Department of Transfusion Medicine, 6th floor Service Block, Dr. E. Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA 
9987815691

dr_priti99@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital, mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy platelet donors 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The donors who fulfil the eligibility criteria for platelet donation, as per SOP, will be included in study. 
 
ExclusionCriteria 
Details  The donors who do not fulfil eligibility criteria for platelet donation, as per SOP, will be excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study immediate & delayed adverse events in plateletpheresis donors.  The adverse events experienced by platelet donors will be analysed over a period of 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
To analyze factors associated with these adverse events if any.  It will be analysed over a period of 4 months 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="1000" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/10/2020 
Date of Study Completion (India) 30/01/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet done 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Platelets are tiny blood cells that help our body to form clots to stop bleeding. Plateletpheresis or platelet donation is the procedure in which blood is drawn from a donor, platelets are separated and the remainder is returned to the donor.

 The procedure is carried out on a machine, called cell separator. The procedure of plateletpheresis  is generally well tolerated and considered safe, involves minimal risk of adverse events. Adverse events of variable severity may occur during or after the plateletpheresis procedure. Adverse events can be divided into immediate & delayed and also local & systemic. Immediate reactions are the ones which are experienced by donor, when he /she is in hospital. Delayed reactions are those which are experienced by donor after leaving the hospital.  Immediate reactions like pain/ swelling at venepuncture site  etc.   are noted in apheresis register and are managed in  the hospital. But Delayed reactions generally go unnoticed.

In this study, the voluntary platelet donors willing to participate in the study are telephonically contacted between day 7- day 8 of their platelet donation and a set of questionnaire is asked to note down any delayed reactions he / she might have experienced.

Our Institute being an oncology center has around 4000 procedures of plateletpheresis  each year. Analysis of adverse events, immediate & delayed will help to understand susceptible donors, incidence of various adverse events. The study will also help in donor retention, improve donor safety, increase donation frequency & thereby maintaining platelet donor pool & supply.

 

 
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