Table 3. Primary and Secondary Outcomes: Allogeneic Blood Component Transfusions.
| Population | Fibrinogen Concentrate | Cryoprecipitate | Mean Difference (95% CI) | Unadjusted Ratio of LS Means (1-Sided 97.5% CI) | Noninferiority P Value | ||||
|---|---|---|---|---|---|---|---|---|---|
| No. | Median (IQR) | LS Mean (95% CI) | No. | Median (IQR) | LS Mean (95% CI) | ||||
| Primary Outcome: Cumulative Allogeneic Blood Components Transfused Within 24 h After Cardiopulmonary Bypassa | |||||||||
| Primary analysis set | 372 | 12.0 (5.5 to 22.0) |
16.3 (14.9 to 17.8) |
363 | 14.0 (7.0 to 23.0) |
17.0 (15.6 to 18.6) |
−0.73 (−3.10 to 1.64) |
Unadjusted 0.96 (−∞ to 1.09) |
<.001 |
| Adjusted 0.91 (−∞ to 1.03)c |
<.001 | ||||||||
| Per-protocol setb | 364 | 12.0 (6.0 to 22.0) |
16.4 (15.0 to 18.0) |
361 | 14.0 (7.0 to 22.0) |
16.9 (15.5 to 18.5) |
−0.50 (−2.90 to 1.89) |
Unadjusted 0.97 (−∞ to 1.10) |
<.001 |
| Adjusted 0.92 (−∞ to 1.05)c |
<.001 | ||||||||
| Secondary Outcome: Red Blood Cell Transfusions Within 24 h After Cardiopulmonary Bypass | |||||||||
| Primary analysis set | 372 | 2.0 (0.0 to 5.0) |
3.3 (3.0 to 3.7) |
363 | 2.0 (1.0 to 5.0) |
3.3 (2.9 to 3.7) |
0.23 (−0.55 to 1.00) |
1.00 (0 to 1.18) |
.02 |
| Per-protocol set | 364 | 2.0 (0.0 to 5.0) |
3.3 (3.0 to 3.7) |
361 | 2.0 (1.0 to 5.0) |
3.3 (2.9 to 3.7) |
0.25 (−0.53 to 1.03) |
1.01 (0 to 1.18) |
.02 |
| Secondary Outcome: Platelet Transfusions Within 24 h After Cardiopulmonary Bypass | |||||||||
| Primary analysis set | 372 | 8.0 (4.0 to 12.0) |
9.1 (8.3 to 9.9) |
363 | 8.0 (4.0 to 12.0) |
9.7 (8.9 to 10.5) |
−0.46 (−1.70 to 0.78) |
0.94 (−∞ to 1.06) |
<.001 |
| Per-protocol set | 364 | 8.0 (4.0 to 12.0) |
9.1 (8.3 to 10.0) |
361 | 8.0 (4.0 to 12.0) |
9.6 (8.8 to 10.5) |
−0.31 (−1.56 to 0.93) |
0.95 (−∞ to 1.08) |
<.001 |
| Secondary Outcome: Plasma Transfusions Within 24 h After Cardiopulmonary Bypass | |||||||||
| Primary analysis set | 372 | 2.0 (0.0 to 6.0) |
3.9 (3.5 to 4.4) |
363 | 3.0 (0.0 to 6.0) |
4.1 (3.6 to 4.6) |
−0.04 (−0.97 to 0.89) |
0.96 (−∞ to 1.15) |
.008 |
| Per-protocol set | 364 | 2.0 (0.0 to 6.0) |
4.0 (3.5 to 4.5) |
361 | 3.0 (0.0 to 6.0) |
4.0 (3.6 to 4.6) |
0.04 (−0.91 to 0.98) |
0.98 (−∞ to 1.17) |
.01 |
| Secondary Outcome: Cumulative Allogeneic Blood Components Transfused Within 7 d After Start of Surgery | |||||||||
| Primary analysis set | 372 | 15.5 (6.0 to 29.5) |
22.5 (20.5 to 24.7) |
363 | 17.0 (9.0 to 28.0) |
22.3 (20.3 to 24.5) |
0.21 (−3.14 to 3.55) |
Unadjusted 1.01 (0 to 1.15) |
.005 |
| Adjusted 0.96 (−∞ to 1.09)c |
<.001 | ||||||||
| Per-protocol set | 364 | 15.5 (6.0 to 29.0) |
22.5 (20.5 to 24.8) |
361 | 17.0 (9.0 to 28.0) |
22.2 (20.2 to 24.5) |
0.31 (−3.07 to 3.70) |
Unadjusted 1.01 (0 to 1.16) |
.007 |
| Adjusted 0.96 (−∞ to 1.09)c |
<.001 | ||||||||
Abbreviation: LS, least-squares.
a
Units of allogenic blood components counted as follows: each red blood cell unit = 1 unit, each 250-mL plasma unit = 1 unit, each 500-mL plasma unit = 2 units, each platelet dose = 4 units.
b
Per-protocol set excluded patients who did not undergo cardiac surgery with cardiopulmonary bypass, received the incorrect treatment, received less than 80% of the planned dose, or received the first treatment more than 24 hours after cardiopulmonary bypass.
c
Adjusted for critical state before surgery (post hoc analysis).