Adverse events in platelet apheresis donors: A multivariate analysis in a hospital-based program

Objectives: This study was designed to review the incidence of adverse even ts during nearly 20,000 apheresis procedures over a 4-year period in a hosp ital-based program. Methods: Data were obtained from a review of: (1) apher esis adverse event forms (2) hospital or emergency room medical records (3) the databank for donor and procedure-related variables. Adverse events dur ing or after the apheresis procedures were analyzed according to the follow ing categories: (1) complications related to citrate toxicity; (2) hypotens ive or vasovagal episodes; (3) complications or symptoms consistent with co ronary ischemia; (4) complications related to percutaneous needle insertion , and (5) miscellaneous procedure-related events or nonspecific symptoms. S erious adverse events were categorized as persistent or severe hemodynamic changes as well as other events that required further medical evaluation. R esults: Of 19,736 apheresis procedures, 159 (0.81%) were associated with ad verse events. In 2,376 first-time donations, 26 (1.09%) developed adverse e vents compared to 133 (0.77%) of 17,360 repeat procedures (p = 0.10). Seven ty (0.35%) of 159 donation-related adverse events involved hemodynamic or c itrate-related complications and 73 (0.37%) involved venipuncture-related c omplications, of which 2 required subsequent neurologic consultation. The r emaining 23 (0.12%) adverse events involved procedure-related, nonspecific complications. Forty-seven (0.24%) of the 19,736 apheresis procedures were associated with serious adverse events (SAEs). Seven of these serious adver se events required admission to an emergency department, and 2 required hos pitalization for further evaluation. Multivariate analysis revealed that ap heresis machine model, donor gender and weight, the concomitant harvesting of plasma, the frequency of donation, and citrate-related symptoms (e.g. pa resthesias) were independently associated with severe hypotensive reactions . Conclusions: Apheresis procedures have a 150-fold higher incidence of SAE s requiring hospitalization compared to whole blood donation. Identificatio n of donors at risk for complications can facilitate modification of the ap heresis procedure in order to reduce the likelihood of adverse events. Alth ough our study did not demonstrate a cause-effect relationship between plat elet donation and the development of acute coronary syndromes, underlying c ardiovascular disease was detected in 2 donors during or after the apheresi s who were otherwise asymptomatic.