| Journal of Hematology, ISSN 1927-1212 print, 1927-1220 online, Open Access |
| Article copyright, the authors; Journal compilation copyright, J Hematol and Elmer Press Inc |
| Journal website https://jh.elmerpub.com |
Short Communication
Volume 14, Number 4, August 2025, pages 234-239
Fixed-Dose Four-Factor Prothrombin Complex Concentrate for Reversal of Anticoagulation: Evaluation of Efficacy, Safety, and Cost Savings
Tables
| Characteristics | Warfarin (n = 414) | DOACs (n = 127) |
|---|---|---|
| ICH: intracranial hemorrhage; GIB: gastrointestinal bleed; SD: standard deviation; INR: international normalized ratio; DOACs: direct oral anticoagulants; FFP: fresh frozen plasma; 4F-PCC: four-factor prothrombin complex concentrate; IV: intravenous. | ||
| Males (%) | 232 (56) | 77 (61) |
| Mean age (SD) | 71 (15) | 74 (13) |
| Mean weight (SD) | 87 (26) | 85 (22) |
| Anticoagulation indication (%) | ||
| Atrial fibrillation | 248 (60) | 86 (68) |
| Venous thromboembolism | 100 (24) | 34 (26) |
| Other | 66 (16) | 7 (6) |
| Pre-reversal INR (%) | ||
| 2 - 4 | 219 (61) | - |
| 4 - 6 | 58 (16) | |
| > 6 | 84 (23) | |
| DOACs type (%) | - | |
| Apixaban | 85 (67) | |
| Rivaroxaban | 42 (33) | |
| Mean dose of 4F-PCC (SD) | 1,636 (367) | 2,106 (243) |
| Reason for administration (%) | ||
| Pre-procedure | 134 (32) | 15 (12) |
| Bleed | 269 (65) | 111 (87) |
| ICH | 112 (42) | 70 (63) |
| GIB | 81 (30) | 24 (22) |
| Other | 11 (3%) | 1 (1%) |
| IV vitamin K given (%) | 340 (82) | - |
| FFP administered (%) | 74 (18) | 12 (9) |
| Outcomes | Warfarin (n = 414) | DOACs (n = 127) |
|---|---|---|
| DOACs: direct oral anticoagulants; SD: standard deviation; ICH: intracranial hemorrhage; INR: international normalized ratio. | ||
| Post-reversal INR | ||
| < 2 | 341 (89) | - |
| < 1.5 | 215 (56) | |
| Second dose needed (%) | 16 (4) | 5 (4) |
| 30-day hemorrhagic event (%) | 49 (12) | 15 (12) |
| Mean time to event in days (SD) | 9 (7) | 8 (6) |
| 30-day thrombotic event (%) | 23 (6) | 6 (5) |
| Venous thrombosis (%) | 16 (73) | 3 (50) |
| Arterial thrombosis (%) | 6 (27) | 3 (50) |
| Mean time to event in days (SD) | 10 (8) | 9 (11) |
| 30-day mortality | ||
| Non-ICH (%) | 54 (18) | 14 (25) |
| All-cause (%) | 98 (24) | 38 (30) |
| Outcomes | Mean pre-reversal INR | Mean post-reversal INR |
|---|---|---|
| FF: fresh frozen plasma; INR: international normalized ratio; 4F-PCC: four-factor prothrombin complex concentrate. | ||
| 4F-PCC only 15% (n = 64) | 3.0 | 1.6 |
| 4F-PCC and vitamin K 67% (n = 276) | 4.3 | 1.5 |
| 4F-PCC, vitamin K, and FFP 15% (n = 64) | 5.2 | 1.7 |
| Warfarin (n = 16) | DOACs (n = 5) | |
|---|---|---|
| DOACs: direct oral anticoagulants; IQR: interquartile range; 4F-PCC: four-factor prothrombin complex concentrate; ICH: intracranial hemorrhage. | ||
| Median weight, kg (IQR) | 94 (83 - 126) | 95 (86-100) |
| Indication | ||
| Pre-procedure | 8 | |
| Bleeding | 8 (all ICH) | |
| Range of first dose of 4F-PCC, IU | 1,558 - 5,360 | 1,637 - 2,252 |
| 30-day hemorrhagic event (%) | 2 (13) | 3 (60) |
| 30-day thrombotic event (%) | 2 (13) | 0 (0) |
| 30-day mortality | 9 (56) | 2 (40) |