Table 3.
Study | Number | Age, median (IQR) | rFVIIa dose (μg/kg) |
rFVIIa doses received, number | Effect on blood-product requirements or bleeding | Thrombotic events | Deaths, number |
---|---|---|---|---|---|---|---|
Pediatric patients | |||||||
Wittenstein et al. [30] | 4 | 0.625 (0.25-9) months | 90-120 | 2 | ↓81.9% PRC between before and after one rFVIIa infusion ↓90% FFP between before and after one rFVIIa infusion |
0 | 0 |
Velik-Salchner et al. [29] | 1 | 0.5 months | 90 | 1 | Bleeding stopped | 1 (arterial) | 1 |
Dominguez et al. [24] | 2 | 11 and 13 years | 90 | 3 and 10 | ↓88.7% total blood products between 12 hours before and after rFVIIa infusion for case 1 ↓46.7% total blood products between 24 hours before and after rFVIIa infusion for case 2 |
0 | 1 |
Veldman et al. [16] | 7 | 4 (0.4-14.5) months | 83 (61-106) | 3 (2-3.5) | ↓23.1% PRC between before and after one rFVIIa infusion ↓35.3% FFP between before and after one rFVIIa infusion |
0 | 3 |
Argawal et al. [22] | 11a | 9.5 days | 36.5 ± 18.2 | 1.6 ± 7 | ↓42% PRC between before and after one rFVIIa infusion (P < 0.05) ↓59.3% FFP between before and after one rFVIIa infusion (P < .05) |
2 circuit thromboses | 3 |
Chalwin et al. [23] | 1 | 18 months | 90 | 1 | Bleeding stopped | 1 circuit thrombosis | 1 |
Guzzeta et al. [26] | 1 | 5 days | 70 | 2 | ↓66.7% PRC after the two rFVIIa doses ↓100% FFP after two rFVIIa doses |
1 extensive distal thrombotic emboli | 1 |
Schneider et al. [28] | 4b | 6.7 (1-11.2) years | 180 (146.25-180) | 2 (1.75-2) | ↓46.5% (-71.25 to -2.25) PRC between 12 hours before and after rFVIIa infusion 14.5% (-49.5 to 21.5) FFP between 24 hours before and after rFVIIa infusion |
1 stroke | 2 |
Niebler et al. [27] | 17 | 0.1 (0-14) years | 45-90 | 1.5 (1-2) | ↓50% total blood products between before and after rFVIIa infusion (P = 0.05) |
4 clinical thromboses 2 oxygenator failures 2 circuit obstructions |
12 |
Adult patients | |||||||
Bui et al. [17] | 1 | 56 years | 146.5 | 2 | ↓53.8% PRC between the 12 hours before and after rFVIIa infusion ↓16.7% FFP between 12 hours before and after rFVIIa infusion |
1 circuit thrombosis | 1 |
Brose et al. [15] | 1 | 17 years | 220 | 2 | Bleeding stopped (↓90% bleeding after rFVIIa infusion) | 0 | 0 |
Schneider et al. [28] | 5b | 48 (45.2-52) years | 90 (54-105) | 2 (1-2) | ↓61% (-79 to -47) PRC between the 12 hours before and after rFVIIa infusion ↓33% (-58 to 42) FFP between the 24 hours before and after injection of rFVIIa |
0 | 3 |
Syburra et al. [35] | 1 | 58 years | 84.7 | 1 | Bleeding stopped | 1 left atrium thrombosis | 1 |
Dunne et al. [25] | 1 | 63 years | 47 | 1 | Bleeding stopped (↓90% bleeding after rFVIIa infusion) | 0 | 0 |
FFP, fresh-frozen plasma; PRC, packed red cells; rFVIIa, recombinant activated factor VII. aAnalysis concerns 11 of the 12 patients on ECMO who received rFVIIa; one patient did not respond to rFVIIa. bThe authors reported on 12 patients, among whom four were infants with ECMO, five were adults with ECMO, and three were adults with ventricle-assist devices.