Table 1. Characteristics of the Study Population at Baseline.
| Characteristic | No. (%) | |
|---|---|---|
| Fibrinogen Concentrate (n = 372) | Cryoprecipitate (n = 363) | |
| Age, median (IQR), y | 65 (54-72) | 64 (53-72) |
| Sex | ||
| Women | 113 (30.4) | 105 (28.9) |
| Men | 259 (69.6) | 258 (71.1) |
| Race | ||
| White | 287 (77.2) | 273 (75.2) |
| Asian | 51(13.7) | 58 (16.0) |
| Black | 3 (0.81) | 6 (1.6) |
| Aboriginal | 5 (1.3) | 2 (0.55) |
| Othera | 26 (7.0) | 24 (6.6) |
| Body mass index, median (IQR)b | 22.2 (19.6-25.4) | 22.8 (19.6-25.6) |
| NYHA classc | ||
| I (least severe) | 104 (27.9) | 112 (30.8) |
| II | 110 (29.6) | 108 (29.8) |
| III | 110 (29.6) | 103 (28.4) |
| IV (most severe) | 48 (12.9) | 40 (11.0) |
| Myocardial infarction, d | ||
| No. | 367 | 358 |
| None | 294 (80.1) | 299 (83.5) |
| 0-90 | 39 (10.6) | 30 (8.4) |
| >90 | 34 (9.3) | 29 (8.1) |
| Ejection fraction, % | ||
| No. | 357 | 347 |
| >50 | 256 (71.7) | 263 (75.8) |
| 31-50 | 51 (14.3) | 57 (16.4) |
| 21-30 | 28 (7.8) | 12 (3.5) |
| <21 | 22 (6.2) | 15 (4.3) |
| Pulmonary pressure, mm Hg | ||
| No. | 308 | 303 |
| ≤30 | 225 (73.1) | 215 (71.0) |
| 31-55 | 58 (18.8) | 68 (22.4) |
| >55 | 25 (8.1) | 20 (6.6) |
| Hypertension | 234 (62.9) | 240 (66.1) |
| Dyslipidemia | 185 (49.7) | 185 (51.0) |
| Congestive heart failure | 113 (30.4) | 91 (25.1) |
| Atrial fibrillation | 81 (21.8) | 80 (22.0) |
| Diabetes mellitus | 80 (21.5) | 74 (20.4) |
| Chronic lung disease | 53 (14.3) | 37 (10.2) |
| Stroke/TIA | 46 (12.4) | 49 (13.5) |
| Peripheral vascular disease | 37 (10.0) | 34 (9.4) |
| Active endocarditis | 19 (5.1) | 18 (5.0) |
| CCS class IV angina | 15 (4.0) | 13 (3.6) |
| Dialysis (preoperative) | 9 (2.4) | 14 (3.9) |
| Intra-aortic balloon pump | 10 (2.7) | 3 (0.8) |
| VAD/ECMO | 9 (2.4) | 9 (2.5) |
| Critical state before surgeryd | 63 (16.9) | 38 (10.5) |
| Preoperative laboratory values, median (IQR) | ||
| Creatinine, μmol/L | 88 (72-107) [n = 359] |
86 (72-106) [n = 352] |
| Hemoglobin, g/dL | 13.4 (11.6-14.6) [n = 366] |
13.5 (11.7-14.8) [n = 356] |
| Platelet count, ×103/μL | 189 (154-235) [n = 365] |
185 (152-230) [n = 356] |
| International normalized ratio | 1.02 (0.98-1.20) [n = 335] |
1.03 (0.98-1.15) [n = 334] |
| Surgical factors | ||
| Nonelective surgery | 141 (37.9) | 128 (35.3) |
| Complex surgerye | 267 (71.8) | 260 (71.6) |
| Procedure (% of procedures)f | 653 (100.0) | 612 (100.0) |
| Aortic valve procedure | 165 (25.3) | 146 (23.9) |
| Surgery on aorta | 161 (24.7) | 177 (28.9) |
| CABG surgery | 153 (23.4) | 146 (23.9) |
| Mitral valve procedure | 68 (10.4) | 70 (11.4) |
| Tricuspid valve procedure | 31 (4.7) | 35 (5.7) |
| ASD/VSD repair | 20 (3.1) | 8 (1.3) |
| Heart transplant | 18 (2.8) | 10 (1.6) |
| Complex congenital | 11 (1.7) | 11 (1.8) |
| Otherg | 26 (4.0) | 9 (1.5) |
| Cardiopulmonary bypass duration, median (IQR), min | 143 (102-209) | 134 (99-200) |
Abbreviations: ASD, atrial septal defect; CABG, coronary artery bypass graft; CCS, Canadian Cardiovascular Society; ECMO, extracorporeal membrane oxygenation; IQR, interquartile range; NYHA, New York Heart Association; TIA, transient ischemic attack; VAD, ventricular assist device; VSD, ventricular septal defect.
Other races marked as unknown or not applicable.
Calculated as weight in kilograms divided by height in meters squared.
NYHA functional classification: I = no limitation of physical activity and no symptoms; II = slight limitation of physical activity (ordinary physical activity results in fatigue, palpitation, dyspnea); III = marked limitation of physical activity (less than ordinary activity causes fatigue, palpitation, or dyspnea); IV = unable to carry on any physical activity without discomfort (symptoms of heart failure at rest).
Determined by blinded adjudication for patients who underwent emergency surgery deemed to be in a critical state, based on criteria outlined in Supplement 2.
Procedures other than CABG surgery only, single valve only, or repair of atrial septal defect only.
Totals exceed 100% because some patients underwent more than 1 procedure.
Examples of other procedures included aortic root enlargement, left ventricular aneurysmectomy, and left atrial appendage resection.