Journal of Pharmacovigilance

Frequency of adverse events in plateletpheresis donors in regional transfusion centre in North India

4^th International Conference and Exhibition on Pharmacovigilance & Clinical Trials

August 10-12, 2015 London, UK

Gopal Kumar Patidar, Ratti Ram Sharma and Neelam Marwaha

Posters-Accepted Abstracts: J Pharmacovigilance

Abstract:

We planned this prospective study to look into donor safety aspect by studying adverse events in normal healthy plateletpheresis donors. In this study we included 500 healthy, first-time (n=301) and repeat (n=199) plateletpheresis donors after informed consent. The plateletpheresis procedures were performed on TrimaAccel (5.1 version, GAMBRO BCT) and Amicus (3.2 version FENWAL) cell separators. The adverse events during procedure were recorded and classified according to their nature. In results we found a total of 18% (n=90) adverse events were recorded in 500 plateletpheresis donors, of which 9% of were hypocalcaemia in nature followed by hematoma (7.4%), vasovagal reaction (0.8%) and kit related adverse events in (0.8%). There was significant postprocedure drop in Hb, Hct, platelet count of the donors (p<0.0001) whereas WBC count showed a statistically significant rise (p<0.0001). Divalent cations (iCa+, TCa+, TMg+) also showed a statistically significant decline after donation (p<0.0001). However there were no statistically significance differences between adverse events in TrimaAccel (5.1 version, GAMBRO BCT) and Amicus (3.2 version FENWAL) cell separators. Donor reactions can adversely affect the voluntary donor recruitment strategies to increase the public awareness regarding constant need for blood and blood products. Commonly observed adverse events in plateletpheresis donors were hypocalcemia, hematoma formation and vasovagal reactions which can be prevented by pre-donation education of the donors and change of machine configuration.