Table 4. Treatment-Emergent Adverse Events and Other Measured Outcomes at 28-Day Follow-up.
| Outcome | No. (%) | |
|---|---|---|
| Fibrinogen Concentrate (n = 372) | Cryoprecipitate (n = 363) | |
| Any adverse event | 248 (66.7) | 264 (72.7) |
| No. of events | 623 | 673 |
| Any serious adverse event | 117 (31.5) | 126 (34.7) |
| No. of events | 224 | 264 |
| Thromboembolic adverse eventsa | 26 (7.0) | 35 (9.6) |
| No. of events | 27 | 39 |
| Stroke/TIA | 17 (4.6) | 18 (5.0) |
| DVT/PE | 5 (1.3) | 9 (2.5) |
| Myocardial infarction | 3 (0.8) | 4 (1.1) |
| Other vessel thrombosis | 0 | 7 (1.9) |
| Amaurosis fugax | 0 | 1 (0.3) |
| Disseminated intravascular coagulation | 1 (0.3) | 0 |
| Thrombophlebitis | 1 (0.3) | 0 |
| Acute kidney injuryb | 48 (12.9) | 48 (13.2) |
| Hepatobiliary disordersc | 32 (8.6) | 37 (10.2) |
| Duration of mechanical ventilation, median (IQR), d | 1.3 (0.7-5.0) [n = 337] | 1.3 (0.7-4.2) [n = 342] |
| Duration of intensive care unit stay, median (IQR), d | 2.9 (1.4-5.7) [n = 352] | 2.8 (1.2-5.6) [n = 345] |
| Duration of hospitalization, median (IQR), d | 8.2 (6.3-13.0) [n = 314] | 9.0 (6.3-13.3) [n = 308] |
Abbreviations: DVT, deep vein thrombosis; PE, pulmonary embolism; TIA, transient ischemic attack.
a
Patients who experienced more than 1 event are counted only once in the total.
b
Acute kidney injury was defined as greater than a 2-fold increase in creatinine or kidney failure requiring hemodialysis within 28 days of surgery.
c
Hepatobiliary disorders were defined by the Medical Dictionary for Regulatory Activities (version 21.1) system of nomenclature.