Analysis of adverse events in voluntary platelet donors.

Completed

Conditions: Healthy platelet donors

Registration Number: CTRI/2020/10/028311

Lead Sponsor: Tata Memorial Hospital

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 1000

Inclusion Criteria

The donors who fulfil the eligibility criteria for platelet donation, as per SOP, will be included in study.

Exclusion Criteria

The donors who do not fulfil eligibility criteria for platelet donation, as per SOP, will be excluded from the study.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
To analyze factors associated with these adverse events if any.	It will be analysed over a period of 4 months

Trial Locations

Locations (1): Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Priti Desai
Principal investigator
9987815691
dr_priti99@yahoo.com