Table 3.
Results of unadjusted and adjusted regression models for outcomes. ∗Adjusted model results accounted for surgical complexity (complex procedures were those other than coronary artery bypass surgery only, single valve only, or repair of atrial septal defect only), urgency (non-elective vs elective status), critical preoperative status (determined by blinded adjudication on patients who underwent emergency surgery and had any of the following conditions: (1) ventricular tachycardia or fibrillation or cardiac arrest; (2) preoperative cardiac massage; (3) preoperative ventilation before anaesthetic room; (4) haemodynamic support requiring preoperative inotropes or ventricular assist devices; (5) preoperative acute renal failure [anuria or oliguria]), sex, and age. CI, confidence interval.
| Outcome 1: Number of packed red blood cells transfused within 24 h of cardiopulmonary bypass Poisson regression accounting for clustering by study site | ||||||
|---|---|---|---|---|---|---|
| Fibrinogen arm (n=372) | Cryoprecipitate arm (n=363) | |||||
| Unadjusted results | ||||||
| Quartile | Number of red blood cells transfused | Relative risk (95% CI) | P-value | Number of red blood cells transfused | Relative risk (95% CI) | P-value |
| 1 2 3 4 |
349 336 272 277 |
Reference 1.03 (0.67–1.58) 0.83 (0.66–1.05) 0.84 (0.65–1.10) |
0.90 0.12 0.21 |
345 232 350 274 |
Reference 0.72 (0.47–1.12) 1.04 (0.73–1.48) 0.81 (0.60–1.08) |
0.14 0.84 0.15 |
| Adjusted results∗ | ||||||
| Quartile | Number of red blood cells transfused | Relative risk (95% CI) | P-value | Number of red blood cells transfused | Relative risk (95% CI) | P-value |
| 1 2 3 4 |
349 336 272 277 |
Reference 1.04 (0.77–1.40) 0.89 (0.70–1.15) 0.90 (0.71–1.13) |
0.81 0.38 0.36 |
345 232 350 274 |
Reference 0.82 (0.52–1.27) 1.17 (0.85–1.60) 1.04 (0.76–1.43) |
0.37 0.33 0.80 |
|
Outcome 2: number of all allogeneic product transfusions within 24 h of cardiopulmonary bypass (red blood cells, frozen plasma, platelets) Poisson regression accounting for clustering by study site | ||||||
|---|---|---|---|---|---|---|
| Fibrinogen arm (n=372) | Cryoprecipitate arm (n=363) | |||||
| Unadjusted results | ||||||
| Quartile | Number of blood products transfused | Relative risk (95% CI) | P-value | Number of blood products transfused | Relative risk (95% CI) | P-value |
| 1 2 3 4 |
1003 927 677 771 |
Reference 1.01 (0.77–1.31) 0.75 (0.63–0.89) 0.83 (0.69–1.00) |
0.97 0.0009 0.05 |
1083 671 902 721 |
Reference 0.69 (0.49–0.96) 0.89 (0.64–1.25) 0.73 (0.59–0.90) |
0.03 0.51 0.003 |
| Adjusted results∗ | ||||||
| Quartile | Number of blood products transfused | Relative risk (95% CI) | P-value | Number of blood products transfused | Relative risk (95% CI) | P-value |
| 1 2 3 4 |
1003 927 677 771 |
Reference 1.02 (0.87–1.20) 0.83 (0.69–1.00) 0.90 (0.78–1.04) |
0.81 0.05 0.16 |
1083 671 902 721 |
Reference 0.78 (0.55–1.11) 0.99 (0.73–1.34) 0.92 (0.70–1.21) |
0.17 0.95 0.56 |
|
Outcome 3: return to the operating room for re-exploration because of bleeding or tamponade Logistic regression accounting for clustering by study site | ||||||
|---|---|---|---|---|---|---|
| Fibrinogen arm (n=372) | Cryoprecipitate arm (n=363) | |||||
| Unadjusted results | ||||||
| Quartile | Number of events | Odds ratio (95% CI) | P-value | Number of events | Odds ratio (95% CI) | P-value |
| 1 2 3 4 |
13 12 17 8 |
Reference 0.93 (0.55–1.59) 1.39 (0.82–2.36) 0.59 (0.32–1.09) |
0.79 0.22 0.09 |
9 13 11 14 |
Reference 1.66 (0.65–4.23) 1.30 (0.59–2.89) 1.73 (0.67–4.49) |
0.29 0.51 0.26 |
| Adjusted results∗ | ||||||
| Quartile | Number of events | Odds ratio (95% CI) | P-value | Number of events | Odds ratio (95% CI) | P-value |
| 1 2 3 4 |
13 12 17 8 |
Reference 0.89 (0.46–1.70) 1.40 (0.80–2.44) 0.49 (0.23–1.04) |
0.72 0.24 0.06 |
9 13 11 14 |
Reference 1.29 (0.45–3.72) 1.20 (0.41–3.48) 1.80 (0.49–6.58) |
0.63 0.74 0.37 |
|
Outcome 4: thromboembolic and ischaemic complications (stroke, myocardial infarction, intra-abdominal or limb ischaemia, pulmonary embolism, and venous thrombosis) Logistic regression accounting for clustering by study site | ||||||
|---|---|---|---|---|---|---|
| Fibrinogen arm (n=372) | Cryoprecipitate arm (n=363) | |||||
| Unadjusted results | ||||||
| Quartile | Number of events | Odds ratio (95% CI) | P-value | Number of events | Odds ratio (95% CI) | P-value |
| 1 2 3 4 |
8 8 12 9 |
Reference 1.04 (0.41–2.62) 1.58 (0.67–3.75) 1.17 (0.47–2.92) |
0.93 0.30 0.74 |
9 9 13 14 |
Reference 1.10 (0.37–3.30) 1.59 (0.71–3.57) 1.70 (0.68–4.22) |
0.86 0.26 0.25 |
| Adjusted results∗ | ||||||
| Quartile | Number of events | Odds ratio (95% CI) | P-value | Number of events | Odds ratio (95% CI) | P-value |
| 1 2 3 4 |
8 8 12 9 |
Reference 0.94 (0.38–2.34) 1.67 (0.64–4.40) 0.92 (0.40–2.11) |
0.90 0.30 0.85 |
9 9 13 14 |
Reference 1.37 (0.42–4.46) 1.79 (0.70–4.59) 1.98 (0.73–5.36) |
0.60 0.22 0.18 |