Table 1.
Baseline characteristics and perioperative data. *Before the start of surgery. †Measured at the central laboratory. ‡Fibrinogen concentration at the time of measurement of the first 5 min bleeding mass, measured using the Clauss assay (central laboratory). CPB, cardiopulmonary bypass; FCH, human fibrinogen concentrate; IQR, interquartile range; MCF, maximum clot firmness; TAA, thoracic aortic aneurysm; TAAA, thoraco-abdominal aortic aneurysm; TRUST, transfusion risk understanding scoring tool
| Parameter | FCH (n=78) | Placebo (n=74) |
|---|---|---|
| Sex [n (%)] | ||
| Female | 18 (23.1) | 23 (31.1) |
| Male | 60 (76.9) | 51 (68.9) |
| Age [yr; mean (range)] | 63.9 (22–86) | 64.2 (24–86) |
| BMI [kg m−2; mean (sd)] | 25.7 (4.6) | 25.6 (4.6) |
| Race [n (%)] | ||
| Asian | 27 (34.6) | 24 (32.4) |
| White | 51 (65.4) | 49 (66.2) |
| Other | 0 | 1 (1.4) |
| Surgery type [n (%)] | ||
| TAAA repair | 3 (3.8) | 4 (5.4) |
| TAA repair with proximal arch | 32 (41.0) | 36 (48.6) |
| TAA repair without proximal arch | 43 (55.1) | 34 (45.9) |
| Unknown | 0 | 3 (4.1) |
| TRUST score | ||
| Mean (sd) | 2.2 (1.42) | 2.4 (1.59) |
| Plasma fibrinogen* (g litre−1) | ||
| n | 73 | 68 |
| Mean (sd) | 3.03 (0.92) | 3.06 (0.83) |
| FIBTEM MCF* (mm) | ||
| n | 70 | 66 |
| Mean (sd) | 16.3 (4.7) | 16.5 (5.2) |
| Duration of CPB [n (%)] | ||
| <120 min | 13 (16.7) | 10 (13.5) |
| 120–180 min | 30 (38.5) | 25 (33.8) |
| >180 min | 35 (44.9) | 39 (52.7) |
| Duration of circulatory arrest [n (%)] | ||
| 0 | 53 (67.9) | 41 (55.4) |
| >0 and <30 min | 18 (23.1) | 22 (29.7) |
| 30–60 min | 6 (7.7) | 7 (9.5) |
| >60 min | 1 (1.3) | 4 (5.4) |
| Lowest core temperature (°C) | ||
| n | 78 | 74 |
| Mean (sd) | 28.8 (5.4) | 28.1 (5.5) |
| First 5 min bleeding mass (g) | ||
| n | 78 | 74 |
| Median (IQR) | 107.0 (76.0–138.0) | 91.0 (71.0–112.0) |
| Platelet count at first 5 min bleeding mass† (×109 litre−1) | ||
| n | 70 | 69 |
| Mean (sd) | 102.4 (48.76) | 90.4 (35.7) |
| Last platelet count before administration of study medication [n (%)] | ||
| <100×109 litre−1 | 38 (48.7) | 38 (51.4) |
| ≥100×109 litre−1 | 40 (51.3) | 36 (48.6) |
| Plasma fibrinogen before administration of study medication‡ (g litre−1) | ||
| n | 74 | 70 |
| Mean (sd) | 1.86 (0.66) | 1.77 (0.51) |