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

Abstract

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.

Donor Hemovigilance during Preparatory Plasmapheresis

“…Severe outcomes [30,43], arterial puncture [44], citrate toxicity, severe injuries to subcutaneous nerves [45,46,47,48,49,50], thrombosis of upper extremity veins [51,52], formation of an arteriovenous fistula [53,54], pseudoaneurysm [55,56,57], or compartment syndrome [58] are all extremely rare, as are some other rare events [59]. We did not see any of these rare UEs [60,61,62]. …”

Donor Safety in Haemapheresis: Development of an Internet-Based Registry for Comprehensive Assessment of Adverse Events from Healthy Donors

“…This is not surprising as both PLSs and PLTs account for the apheresis techniques that are most often applied in Germany [6]. Of note, our system will probably assess more SAEs than previously reported [13][14][15]23]. This is, at least in part, due to assessment of technical (e.g., disposable leakage) and donor characteristics typically associated with deferral from haemapheresis (e.g., blood count abnormalities).…”

“…As shown in table 1, the number of AEs reported in the context of haemapheresis varies by two log steps from 0.025% [9] to 5.77% and 6.55% [10,11]. One explanation for this wide range is that some authors included mild, clinically insignificant donor reactions (e.g., small haematomas, short vasovagal reactions without faint, mild paresthesia [11][12][13][14]), whereas other reports referred to moderate and severe adverse events (SAEs) [14][15][16] or to SAEs only [9,17]. But even within the donor reaction grading 'SAE', the results may vary by 10-fold between 0.025% [9] and 0.24% [13].…”

“…Further largely diverging parameters refer to the choice of the apheresis machines and the apheresis procedures. Some authors report data from one specific apheresis procedure (e.g., PLS [11] or PLT [13,15]), whereas others presented AEs from different procedures simultaneously such as PLT, single or double red blood cell (RA1/RA2) apheresis or multi-component (MC) apheresis [9,14,18,20]. Taken these considerations in mind and given that haemapheresis is a versatile field with different types of apheresis machines and many different technical procedures, it is not surprising that the results obtained from AE studies showed a wide variance.…”

“…Another very important point that impairs the comparability of the reported AE results was the long lasting absence of an internationally accepted standard for assessment and grading of AEs in blood donation. Consequently, 11 out of 14 groups developed own centre-specific systems for assessment and grading of AEs [10,11,[13][14][15][16][19][20][21][22][23]. The remaining groups adopted a standard that had been developed by a scientific society [12] or applied a national (French) standard for donor haemovigilance [9,17].…”