Moderate and severe adverse events associated with apheresis donations: incidences and risk factors.

BACKGROUND: The goal of this observational retrospective study was to evaluate various donor and procedural variables as potential risk factors for different types of moderate to severe adverse events (AEs) during apheresis collections. STUDY DESIGN AND METHODS: Data on all apheresis collections performed on Trima Accel (TA; CaridianBCT) instruments over a 28-month period were extracted from a donor database (Vista Information System, CaridianBCT) and reviewed along with AE reports from the same period. Donor and procedural variables were compared among uneventful procedures and those that resulted in various types of moderate to severe AEs, including presyncopal or syncopal (PS) episodes, citrate reactions (CR), reactions with both components (PS + CR), and self-reported incidents of significant venipuncture-related vascular injuries (VIs). RESULTS: A total of 59 moderate to severe AEs occurred among 15,763 procedures (0.37%), including 19 PS, 4 CR, 17 PS + CR, 12 VI, and 7 miscellaneous reactions. Greater blood loss and lower net fluid balance were associated with PS; female sex, older age, and smaller total blood volume (TBV) were associated with CR; and development of VI may be associated with female sex and smaller TBV. Younger age was not a risk factor for AEs. CONCLUSIONS: Apheresis collections performed by TA instruments are safe with a low incidence of significant AEs. Various types of AEs have different predisposing factors. Apheresis may be a safer option for donors with risk factors for PS reactions associated with whole blood collections, such as younger age, female sex, and small TBV.

Risk factors for acute, moderate to severe donor reactions associated with multicomponent apheresis collections.

BACKGROUND: Legitimate concerns exist over the safety of donors during multicomponent apheresis collections (MACs), when large volumes of red blood cells (RBCs) and plasma are removed. This study evaluates the predictive value of various donor- and procedure-related variables for moderate to severe donor acute adverse events (AAEs). STUDY DESIGN AND METHODS: Data on all apheresis donation procedures performed at a large university hospital-based donor center over a 2-year period were obtained by a review of adverse event forms and procedure logs (Trima Accel 5.1, Gambro BCT). Various donor- and procedure-related variables were compared between procedures that resulted in moderate to severe AAEs and those that did not. RESULTS: Moderate to severe AAEs occurred in 53 (0.47%) of 11,333 apheresis donation procedures. The majority of events (96.2%) had predominantly features of vasovagal reactions (VVRs). Females were at significantly higher risk (odds ratio [OR] = 2.8, p < 0.0003) compared to males. Donors who experienced AAEs had significantly lower predonation total blood volume (TBV) and hematocrit (Hct) and higher total RBC loss and net fluid loss at the end of the procedures. Total plasma loss alone was not significantly different between the two groups. Total blood loss was significantly higher among donors who experienced AAEs as a percentage of the donor's TBV. CONCLUSION: Apheresis collections are well tolerated even when multiple components are collected, with a very low overall incidence of moderate to severe AAEs (0.47%). Small, female donors with lower predonation Hct are at higher risk, especially when RBCs are collected.