title: Frequency of adverse events in plateletpheresis donors in regional transfusion centre in North India.
abstract: BACKGROUND
  Although automated cell separators have undergone a lot of technical refinements, attention has been focused on the quality of platelet concentrates than on donor safety. We planned this prospective study to look into donor safety aspect by studying adverse events in normal healthy plateletpheresis donors.
  
  
  METHODS
  The study included 500 healthy, first-time (n=301) and repeat (n=199) plateletpheresis donors after informed consent. The plateletpheresis procedures were performed on Trima Accel (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. The pre and post procedure hematological and biochemical profiles of these donors were also assessed with the help of automated cell counter and analyser respectively.
  
  
  RESULTS
  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 post procedure 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 difference between adverse events in Trima Accel (5.1 version, GAMBRO BCT) and Amicus (3.2 version FENWAL) cell separators.
  
  
  CONCLUSIONS
  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. Nevertheless, more prospective studies on this aspect are required in order to establish guidelines for donor safety in apheresis and also to help in assessing donor suitability, especially given the present trend of double product apheresis collections.
authors.affiliation: Department of Transfusion Medicine, Post Graduation Institute of Medical Education and Research, Chandigarh, India. Electronic address: drgpatidar@gmail.com.
authors.forename: Gopal Kumar
authors.initials: GK
authors.lastname: Patidar
authors.forename: Ratti Ram
authors.initials: RR
authors.lastname: Sharma
authors.forename: Neelam
authors.initials: N
authors.lastname: Marwaha
mesh_terms: D000293:Adolescent; D000328:Adult; D001782:Blood Donors; D006406:Hematoma / Q000097:blood / Q000453:epidemiology* / Q000209:etiology; D006801:Humans; D006934:Hypercalcemia / Q000097:blood / Q000453:epidemiology* / Q000209:etiology; D007194:India / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010983:Plateletpheresis / Q000009:adverse effects*; D019462:Syncope, Vasovagal / Q000097:blood / Q000453:epidemiology* / Q000209:etiology
keywords: Biochemical values; Cell separator; Donor safety; Hematological values; Platelet count; Plateletpheresis