Table 2. Details of Intervention, Perioperative Laboratory Values, Fibrinogen Levels, and Bleeding.
| Variable | Median (IQR) | |
|---|---|---|
| Fibrinogen Concentrate (n = 372) | Cryoprecipitate (n = 363) | |
| Dosage of investigational product | ||
| Mean (SD) | 4.8 (2.1) g | 12.9 (8.5) units |
| Median (IQR) | 4 (4-4) g | 10 (10-10) units |
| Doses of investigational product, No. (%) | ||
| 1 | 309 (83.1) | 296 (81.5) |
| 2 | 49 (13.2) | 49 (13.5) |
| 3 | 10 (2.7) | 10 (2.8) |
| ≥4 | 4 (1.1) | 8 (2.2) |
| Time from start of surgery to order of first dose, h | 5.8 (4.5-7.3) | 5.8 (4.6-7.1) |
| Time from order of first dose to administration, min | 45 (32-62) | 47 (37-60) |
| Time from end of CPB to administration of first dose, min | 97 (52-159) | 104 (59-160) |
| Plasma fibrinogen level, g/L | ||
| Pretransfusion | 1.6 (1.3-1.9) [n = 352] | 1.6 (1.3-1.9) [n = 346] |
| Posttransfusion | 2.5 (2.1-2.9) [n = 324] | 2.3 (2.0-2.6) [n = 296] |
| Change from pretransfusion | 0.90 (0.6-1.2) [n = 306] | 0.70 (0.5-1.0) [n = 280] |
| Blood components transfused before randomization, mean (SD), units | 4.3 (6.1) | 4.5 (6.0) |
| Cell salvage blood, mL | 373 (0-918) | 400 (0-876) |
| Nadir hematocrit during cardiopulmonary bypass, % | 26 (23-30) | 25 (23-30) |
| Hemoglobin, g/dL | ||
| Intraoperative post-CPB | 9.1 (8.3-9.9) [n = 348] | 8.9 (8.2-9.7) [n = 342] |
| Day of surgery (last recorded value) | 9.6 (8.6-10.9) [n = 365] | 9.5 (8.7-10.7) [n = 356] |
| Postoperative day 1 (last recorded value) | 9.0 (8.3-9.9) [n = 367] | 9.0 (8.3-10.0) [n = 361] |
| Platelet count, ×103/μL | ||
| Intraoperative post-CPB | 107 (84-136) [n = 280] | 103 (81-129) [n = 278] |
| Day of surgery (last recorded value) | 132 (107-165) [n = 362] | 133 (107-163) [n = 353] |
| Postoperative day 1 (last recorded value) | 117 (91-145) [n = 366] | 115 (92-143) [n = 359] |
| International normalized ratio | ||
| Intraoperative post-CPB | 1.6 (1.4-1.8) [n = 295] | 1.6 (1.5-1.8) [n = 277] |
| Day of surgery (last recorded value) | 1.3 (1.2-1.4) [n = 355] | 1.3 (1.2-1.4) [n = 340] |
| Postoperative day 1 (last recorded value) | 1.2 (1.1-1.4) [n = 342] | 1.2 (1.1-1.3) [n = 335] |
| Bleeding categories according to modified UDPB classification, No. (%)a | ||
| ≥2 (moderate to massive) | 349 (93.8) | 347 (95.6) |
| <2 (insignificant to mild) | 23 (6.2) | 16 (4.4) |
| 24-h chest tube drainage, mL | 800 (500-1350) | 830 (540-1350) |
| Reexploration, No. (%) | 53 (14.2) | 44 (12.1) |
| Prothrombin complex concentrate, No. (%) | 110 (29.6) | 98 (27.0) |
| Recombinant factor VII, No. (%) | 35 (9.4) | 28 (7.7) |
Abbreviations: CPB, cardiopulmonary bypass; IQR, interquartile range; UDPB, universal definition of perioperative bleeding.
a
UDPB determinants used in this study include postoperative chest tube output; units of red blood cells, plasma, and platelets transfused; use of factor concentrates; and surgical reexploration (classification scheme included in the eAppendix in Supplement 2).22 For this study the following components of the UDPB score were not used: delay in chest closure and use of cryoprecipitate or fibrinogen concentrate. One intraoperative death was included in the severe or massive category in the fibrinogen concentrate group.