Table II.
Dose and outcome measures according to bleeding context.
| All registry (%) | Cardiac (%) | Trauma (%) | Liver (%) | Other surgery (%) | Obstetric (%) | Haem/onc (%) | ICH (%) | Medical other (%) | Known coagulopathy (%) | |
|---|---|---|---|---|---|---|---|---|---|---|
|
|
||||||||||
| Total cases | 3,446 (100) | 1,535 (45) | 461 (13) | 189 (5) | 604 (18) | 177 (5) | 166 (5) | 83 (2) | 212 (6) | 19 (1) |
|
| ||||||||||
| Total Patients | 3,322 (100) | 1,513 (46) | 453 (14) | 168 (5) | 577 (17) | 175 (5) | 146 (4) | 81 (2) | 191 (6) | 18 (1) |
| Dose | ||||||||||
| Single dose rFVIIa | 2,650 (77) | 1,217 (79) | 352 (76) | 140 (74) | 455 (75) | 134 (76) | 111 (67) | 72 (87) | 156 (74) | 13 (68) |
| Median first dose μg/kg [IQR] | 91 [72–103] | 91 [73–103] | 95 [80–108] | 89 [67–104] | 90 [70–102] | 90 [69–100] | 90 [77–100] | 90 [77–102] | 88 [73–100] | 99 [73–113] |
|
| ||||||||||
| Effect on bleeding after initial dose | ||||||||||
| Stopped | 408 (12) | 207 (13) | 39 (8) | 23 (12) | 61 (10) | 26 (15) | 13 (8) | 11 (13) | 26 (12) | 2 (11) |
| Decreased | 1,600 (46) | 863 (56) | 156 (34) | 61 (32) | 268 (44) | 73 (41) | 62 (37) | 23 (28) | 87 (41) | 7 (37) |
| Unchanged | 949 (28) | 290 (19) | 180 (39) | 77 (41) | 185 (31) | 56 (32) | 61 (37) | 21 (25) | 74 (35) | 5 (26) |
| Effect not known | 489 (14) | 175 (11) | 89 (19) | 28 (15) | 90 (15) | 22 (12) | 30 (18) | 28 (34) | 25 (12) | 5 (26) |
|
| ||||||||||
| Effect on bleeding after final dose | ||||||||||
| Stopped | 485 (14) | 250 (16) | 44 (10) | 28 (17) | 72 (12) | 29 (16) | 17 (10) | 11 (13) | 33 (16) | 1 (5) |
| Decreased | 1,700 (49) | 914 (60) | 168 (36) | 58 (35) | 280 (46) | 85 (48) | 66 (40) | 23 (28) | 89 (42) | 6 (32) |
| Unchanged | 770 (22) | 194 (13) | 162 (35) | 56 (33) | 165 (27) | 41 (23) | 56 (34) | 21 (25) | 61 (29) | 5 (26) |
| Effect not known | 491 (14) | 177 (12) | 87 (19) | 26 (15) | 87 (14) | 22 (12) | 27 (16) | 28 (34) | 29 (14) | 7 (37) |
|
| ||||||||||
| 28-day mortality | ||||||||||
| Deceased | 945 (28) | 249 (16) | 207 (46) | 73 (43) | 205 (36) | 11 (6) | 79 (54) | 39 (48) | 78 (41) | 4 (22) |
a
Final dose equals first dose in patients who received only a single dose.
Haem/Onc: haematology/oncology; ICH: intracranial haemorrhage.