Table 1.
Descriptive characteristics of the study population. IQR, inter-quartile range; sd, standard deviation.
| Fibrinogen arm (n=372 | Cryoprecipitate arm (n=363) | |
|---|---|---|
| Patient characteristics | ||
| Age, yr, median (IQR) | 65 (54, 72) | 64 (53, 72) |
| Sex Female, n (%) Male, n (%) |
113 (30%) 259 (70%) |
105 (29%) 258 (71%) |
| Height, cm, median (IQR) | 170 (161, 178) | 170 (163, 177) |
| Weight, kg, median (IQR) | 76 (65, 87) | 77 (65, 90) |
| BMI, kg m−2, median (IQR) | 22 (20, 25) | 23 (20, 26) |
| Creatinine clearance, ml min−1, median (IQR) | 73 (51, 95) | 74 (50, 96) |
| Diabetes mellitus, n (%) | 80 (22%) | 74 (20%) |
| Chronic lung disease, n (%) | 53 (14%) | 37 (11%) |
| Cerebrovascular disease, n (%) | 46 (12%) | 49 (14%) |
| Left ventricular ejection fraction, n (%) >50% 31–50% 21–31% <21% |
256 (72%) 51 (14%) 28 (8%) 22 (6%) |
263 (76%) 57 (16%) 12 (3%) 15 (4%) |
| Surgical characteristics | ||
| Complex surgery, n (%) | 267 (72%) | 260 (72%) |
| Urgent surgery, n (%) | 141 (38%) | 128 (35%) |
| Critical preoperative Status, n (%) | 64 (17%) | 37 (11%) |
| Cardiopulmonary bypass time, min, median (IQR) | 143 (102, 209) | 134 (99, 200) |
| Perioperative fibrinogen details | ||
| Typical product amount administered per individual dose, g | ||
| Mean (sd) Median (IQR) |
4 (0.23) 4 (4, 4) |
10 (0.13) 10 (10, 10) |
| Weight-adjusted dose, mg kg−1 (Fibrinogen Concentrate) or units per 10 kg (Cryoprecipitate) | ||
| Mean (sd) Median (IQR) |
54 (13) 52 (45, 61) |
1.34 (0.31) 1.30 (1.11, 1.54) |
| Fibrinogen concentration before product administration, g L−1 | ||
| All patients, median (IQR)Patients receiving only one fibrinogen or cryoprecipitate dose, median (IQR) | 1.6 (1.3, 1.9) [n=352] 1.60 (1.33, 1.90) [n=293] |
1.6 (1.3, 1.9) [n=346] 1.66 (1.35, 1.92) [n=287] |
| Fibrinogen concentration after product administration, g L−1 | ||
| All patients, median (IQR)Patients receiving only one fibrinogen or cryoprecipitate dose, median (IQR) | 2.5 (2.1, 2.9) [n=324] 2.58 (2.23, 2.96) [n=267] |
2.3 (2.0, 2.6) [n=296] 2.40 (2.11, 2.71) [n=233] |
| Plasma fibrinogen concentration change after product administration, g L−1 | ||
| All patients, median (IQR)Patients receiving only one fibrinogen or cryoprecipitate dose, Median (IQR) | 0.90 (0.6, 1.2) [n=306] 0.96 (0.74, 1.28) [n=252] |
0.70 (0.5, 1.0) [n=280] 0.78 (0.52, 1.00) [n=225] |
| Bleeding and transfusion within 24 h of separation from cardiopulmonary bypass | ||
| Packed red blood cells, units, median (IQR) | 2 (0, 5) | 2 (1, 5) |
| Platelets, units, median (IQR) | 2 (1, 3) | 2 (1, 3) |
| Frozen plasma, units, median (IQR) | 2 (0, 4) | 2 (0, 4) |
| 24 h chest tube output, ml, median (IQR) | 800 (500, 1350) | 830 (540, 1350) |