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
|
|
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
|
|
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
|
|
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. |