Table 1.
AEs in haemaphereses: literature overview
| Reference | Design | Apheresis devices | Adverse events, categories | Grading – design | Apheresis procedures, types, n | Results |
||
|---|---|---|---|---|---|---|---|---|
| AE, % | grading: M, MOD, SAE | |||||||
| Danic et al., 2010 [9] | RS, multi-centre | n. a. | BAI, VVR, CT | French national agency ‘Afssaps’ | MC, 1,499,469 | 0.025% | SAE = 0.025% | |
| Eder et al., 2008 [10] | PS, single-centre | Amicus, Spectra, Trima | BAI, VVR, CT | centre-specific (ARC) | R2, 228,183; PLT 449,594, in total 677,777 | PLT 5.77%; R2 5.38% | MAJ = 0.45% | |
| Diekamp et al., 2014 [11] | PS, multi-centre | n. a. | BAI, VVR, CT, DC, TE | centre-specific (Haema) | PLS, 1,107,846 | 6.55% | M = 2.18% MOD = 0.27% SAE = 0.06%. |
|
| McLeod et al., 1998 [12] | PS, multi-centre | Fenwal CS3000, Haemonetics MCS, Spectra | BAI, VVR, CT | centre-specific (AABB) | PLT, 17,591; PLS, 1,353; GA, 588; others, 79; in total 19,611 | 2.18% | n.d. | |
| Despotis et al., 1999 [13] | RS, single-centre | Amicus, Fenwal CS3000, Spectra | BAI, VVR, CT, TE | centre-specific | PLT, 19,736 | 0.81% | SAE = 0.24% | |
| Yuan et al., 2008 [14] | RS, single-centre | Trima Accel | VVR, CT | centre-specific | MC, 11,333 | n.a. | MOD = 0.27% SAE = 0,20% |
|
| Yuan et al., 2010 [15] | RS, single-centre | Trima Accel | BAI, VVR, CT | centre-specific | PLT, 15,763 | n.a. | MOD+SAE = 0.37% | |
| Wiltbank et al., 2007 [16] | RS, multi-centre | Alyx, Amicus, MCS+, Spectra, Trima | VVR | centre-specific (UBS) | R2, 249,154; R1 40,870; PLT 90,082; in total 380,106 | n.a. | MOD = 0,14% SAE = 0.035% |
|
| Ounnoughene et al., 2013 [17] | RS, multi-centre | n. a. | BAI, VVR, CT | French national haemovigilance database ‘e-FIT’ | n.a. | n.a. | SAE = 0.18% | |
| Bueno et al., 2006 [18] | RS, single-centre | Trima, Amicus | BAI | n.d. | MC, 5,177 | 3.3% | n.d. | |
| Tomita et al., 2002 [19] | RS, single-centre | MCS 3P | VVR | n.d. | AD: males, n = 14,523; females, n = 6,722 | ♂1–2%, ♀4–5% | n.d. | |
| Kamel et al., 2010 [20] | RS, multi-centre | n.a. | VVR, delayed vs immediate | centre-specific (UBS) | R2, 164,179; PLT/P, 54,841; R1/PLT/PLS, 18,790; in total 237,810 | 0.18% | n.a. | |
| Crocco et al., 2009 [21] | RS, 2 centres | MCS+, PCS+, Trima Accel, always SN | VVR, CT | centre-specific | PLS, 38,647; PLT, 2,641; MC, 8,784; in total 50,072 | 0.63% | SAE ≤ 0.01% | |
AD = Apheresis donors; DC = donor compliance; GA = granulocyte apheresis; M = mild; MC = multi-component apheresis; MOD = moderate; n.a. = not available; n.d. = not done; PLT/PLS = plateletpheresis/plasmapheresis combined; PS = prospective; R1/R2 = single red cell apheresis/double red cell apheresis; R1/PLT/P = single red cell/platelet/plasma-apheresis, combined; RS = retrospective; SAE = severe adverse event; TE = technical events.