Proportion of patients (%) with coagulation factor levels >50% from the start of infusion after treatment with 4F-PCC or plasma
| Factor . | 4F-PCC (n = 185) (%) . | Plasma (n = 184) (%) . | P-value (4F-PCC vs plasma) . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| All . | INR ≤1.5 . | INR >1.5 . | All . | INR ≤1.5 . | INR >1.5 . | All . | INR ≤1.5 . | INR >1.5∗ . | |
| FII | |||||||||
| Time after start of infusion | |||||||||
| 0.5 hours | 144 (90.6) | 130 (95.6) | 14 (60.9) | 24 (14.7) | 11 (17.7) | 13 (13.0) | < .0001 | < .0001 | < .0001 |
| 1 hour | 158 (93.5) | 141 (96.6) | 17 (73.9) | 30 (17.9) | 14 (20.6) | 16 (16.2) | < .0001 | < .0001 | < .0001 |
| 3 hours | 150 (96.2) | 136 (97.8) | 14 (82.4) | 41 (27.2) | 20 (35.7) | 21 (22.1) | < .0001 | < .0001 | < .0001 |
| 6 hours | 136 (93.8) | 122 (96.8) | 14 (73.7) | 54 (35.1) | 27 (45.8) | 27 (28.4) | < .0001 | < .0001 | .0002 |
| 12 hours | 89 (92.7) | 77 (95.1) | 12 (80.0) | 49 (50.0) | 24 (68.6) | 25 (39.7) | < .0001 | .0003 | .0082 |
| 24 hours | 156 (90.2) | 141 (94.6) | 15 (62.5) | 121 (69.9) | 56 (81.2) | 65 (63.1) | < .0001 | .0017 | .96 |
| FVII | |||||||||
| Time after start of infusion | |||||||||
| 0.5 hours | 83 (52.2) | 74 (54.4) | 9 (39.1) | 32 (19.6) | 13 (21.0) | 19 (19.0) | < .0001 | < .0001 | .038 |
| 1 hour | 84 (49.7) | 79 (54.1) | 5 (21.7) | 44 (26.2) | 22 (32.4) | 22 (22.2) | < .0001 | .003 | .96 |
| 3 hours | 77 (49.4) | 72 (51.8) | 5 (29.4) | 49 (32.4) | 29 (51.8) | 20 (21.0) | .0026 | .999 | .45 |
| 6 hours | 85 (58.6) | 79 (62.7) | 6 (31.6) | 69 (44.8) | 37 (62.7) | 32 (33.7) | .017 | .999 | .86 |
| 12 hours | 68 (70.8) | 62 (76.5) | 6 (40.0) | 75 (76.5) | 33 (94.3) | 42 (66.7) | .37 | .033 | .056 |
| 24 hours | 138 (79.8) | 125 (83.9) | 13 (54.2) | 150 (86.7) | 66 (95.6) | 83 (80.6) | .084 | .014 | .0067 |
| FIX | |||||||||
| Time after start of infusion | |||||||||
| 0.5 hours | 126 (79.2) | 116 (85.3) | 10 (43.5) | 77 (47.2) | 36 (58.1) | 40 (40.0) | < .0001 | < .0001 | .76 |
| 1 hour | 140 (82.8) | 128 (87.7) | 12 (52.2) | 78 (46.4) | 42 (61.8) | 35 (35.4) | < .0001 | < .0001 | .14 |
| 3 hours | 132 (84.6) | 122 (87.8) | 10 (58.8) | 87 (57.6) | 38 (67.9) | 49 (51.6) | < .0001 | .001 | .58 |
| 6 hours | 125 (86.2) | 113 (89.7) | 12 (63.2) | 118 (76.6) | 51 (86.4) | 67 (70.5) | .034 | .52 | .52 |
| 12 hours | 79 (82.3) | 70 (86.4) | 9 (60.0) | 86 (87.8) | 34 (97.1) | 52 (82.5) | .29 | .1 | .057 |
| 24 hours | 144 (83.2) | 130 (87.2) | 14 (58.3) | 159 (91.9) | 67 (97.1) | 91 (88.4) | .015 | .025 | .0005 |
| FX | |||||||||
| Time after start of infusion | |||||||||
| 0.5 hours | 142 (89.3) | 127 (93.4) | 15 (65.2) | 16 (9.8) | 7 (11.3) | 9 (9.0) | < .0001 | < .0001 | < .0001 |
| 1 hour | 156 (92.3) | 140 (95.9) | 16 (69.6) | 17 (10.1) | 8 (11.8) | 9 (9.1) | < .0001 | < .0001 | < .0001 |
| 3 hours | 144 (92.3) | 134 (96.4) | 10 (58.8) | 21 (13.9) | 11 (19.6) | 10 (10.5) | < .0001 | < .0001 | < .0001 |
| 6 hours | 134 (92.4) | 121 (96.0) | 13 (68.4) | 34 (22.1) | 16 (27.1) | 18 (19.0) | < .0001 | < .0001 | < .0001 |
| 12 hours | 88 (91.7) | 77 (95.1) | 11 (73.3) | 35 (35.7) | 17 (48.6) | 18 (28.6) | < .0001 | < .0001 | .0023 |
| 24 hours | 153 (88.4) | 139 (93.3) | 14 (58.3) | 110 (63.6) | 53 (76.8) | 56 (54.4) | < .0001 | .0005 | .73 |
| Factor . | 4F-PCC (n = 185) (%) . | Plasma (n = 184) (%) . | P-value (4F-PCC vs plasma) . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| All . | INR ≤1.5 . | INR >1.5 . | All . | INR ≤1.5 . | INR >1.5 . | All . | INR ≤1.5 . | INR >1.5∗ . | |
| FII | |||||||||
| Time after start of infusion | |||||||||
| 0.5 hours | 144 (90.6) | 130 (95.6) | 14 (60.9) | 24 (14.7) | 11 (17.7) | 13 (13.0) | < .0001 | < .0001 | < .0001 |
| 1 hour | 158 (93.5) | 141 (96.6) | 17 (73.9) | 30 (17.9) | 14 (20.6) | 16 (16.2) | < .0001 | < .0001 | < .0001 |
| 3 hours | 150 (96.2) | 136 (97.8) | 14 (82.4) | 41 (27.2) | 20 (35.7) | 21 (22.1) | < .0001 | < .0001 | < .0001 |
| 6 hours | 136 (93.8) | 122 (96.8) | 14 (73.7) | 54 (35.1) | 27 (45.8) | 27 (28.4) | < .0001 | < .0001 | .0002 |
| 12 hours | 89 (92.7) | 77 (95.1) | 12 (80.0) | 49 (50.0) | 24 (68.6) | 25 (39.7) | < .0001 | .0003 | .0082 |
| 24 hours | 156 (90.2) | 141 (94.6) | 15 (62.5) | 121 (69.9) | 56 (81.2) | 65 (63.1) | < .0001 | .0017 | .96 |
| FVII | |||||||||
| Time after start of infusion | |||||||||
| 0.5 hours | 83 (52.2) | 74 (54.4) | 9 (39.1) | 32 (19.6) | 13 (21.0) | 19 (19.0) | < .0001 | < .0001 | .038 |
| 1 hour | 84 (49.7) | 79 (54.1) | 5 (21.7) | 44 (26.2) | 22 (32.4) | 22 (22.2) | < .0001 | .003 | .96 |
| 3 hours | 77 (49.4) | 72 (51.8) | 5 (29.4) | 49 (32.4) | 29 (51.8) | 20 (21.0) | .0026 | .999 | .45 |
| 6 hours | 85 (58.6) | 79 (62.7) | 6 (31.6) | 69 (44.8) | 37 (62.7) | 32 (33.7) | .017 | .999 | .86 |
| 12 hours | 68 (70.8) | 62 (76.5) | 6 (40.0) | 75 (76.5) | 33 (94.3) | 42 (66.7) | .37 | .033 | .056 |
| 24 hours | 138 (79.8) | 125 (83.9) | 13 (54.2) | 150 (86.7) | 66 (95.6) | 83 (80.6) | .084 | .014 | .0067 |
| FIX | |||||||||
| Time after start of infusion | |||||||||
| 0.5 hours | 126 (79.2) | 116 (85.3) | 10 (43.5) | 77 (47.2) | 36 (58.1) | 40 (40.0) | < .0001 | < .0001 | .76 |
| 1 hour | 140 (82.8) | 128 (87.7) | 12 (52.2) | 78 (46.4) | 42 (61.8) | 35 (35.4) | < .0001 | < .0001 | .14 |
| 3 hours | 132 (84.6) | 122 (87.8) | 10 (58.8) | 87 (57.6) | 38 (67.9) | 49 (51.6) | < .0001 | .001 | .58 |
| 6 hours | 125 (86.2) | 113 (89.7) | 12 (63.2) | 118 (76.6) | 51 (86.4) | 67 (70.5) | .034 | .52 | .52 |
| 12 hours | 79 (82.3) | 70 (86.4) | 9 (60.0) | 86 (87.8) | 34 (97.1) | 52 (82.5) | .29 | .1 | .057 |
| 24 hours | 144 (83.2) | 130 (87.2) | 14 (58.3) | 159 (91.9) | 67 (97.1) | 91 (88.4) | .015 | .025 | .0005 |
| FX | |||||||||
| Time after start of infusion | |||||||||
| 0.5 hours | 142 (89.3) | 127 (93.4) | 15 (65.2) | 16 (9.8) | 7 (11.3) | 9 (9.0) | < .0001 | < .0001 | < .0001 |
| 1 hour | 156 (92.3) | 140 (95.9) | 16 (69.6) | 17 (10.1) | 8 (11.8) | 9 (9.1) | < .0001 | < .0001 | < .0001 |
| 3 hours | 144 (92.3) | 134 (96.4) | 10 (58.8) | 21 (13.9) | 11 (19.6) | 10 (10.5) | < .0001 | < .0001 | < .0001 |
| 6 hours | 134 (92.4) | 121 (96.0) | 13 (68.4) | 34 (22.1) | 16 (27.1) | 18 (19.0) | < .0001 | < .0001 | < .0001 |
| 12 hours | 88 (91.7) | 77 (95.1) | 11 (73.3) | 35 (35.7) | 17 (48.6) | 18 (28.6) | < .0001 | < .0001 | .0023 |
| 24 hours | 153 (88.4) | 139 (93.3) | 14 (58.3) | 110 (63.6) | 53 (76.8) | 56 (54.4) | < .0001 | .0005 | .73 |
Number and percentage of patients treated with 4F-PCC or plasma with FII, FVII, FIX, and FX levels >50% at 0.5 hours, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours after the start of infusion. Patients were stratified based on their INR being ≤1.5 or >1.5; the number and percentage of patients with INR ≤1.5 who had VDKF levels >50% after treatment with 4F-PCC or plasma and equally for patients with INR >1.5 are also reported.
∗ The statistical significance between 4F-PCC and plasma for all patients, patients with INR ≤1.5, and with INR >1.5 for each VKDF and time after the start of infusion is provided in the last column.