| Ulinastatin group (n = 142) | Tranexamic acid group (n = 143) | Placebo group (n = 141) | P | |||||
---|---|---|---|---|---|---|---|---|---|
Bleeding | |||||||||
 Blood loss within 8 h postoperatively (ml) | 404.87 ± 253.58 | 380.56 ± 274.3 | 527.73 ± 300.4 | < 0.001 | |||||
 Blood loss 9–16 h postoperatively (ml) | 183.94 ± 151.83 | 165.28 ± 98.02 | 205.57 ± 129.57 | 0.004 | |||||
 Blood loss 17–24 h postoperatively (ml) | 99.58 ± 94.75 | 91.08 ± 61.64 | 121.03 ± 101.62 | 0.034 | |||||
 Blood loss within 24 h postoperatively (ml) | 688.39 ± 393.55 | 636.92 ± 368.87 | 854.33 ± 434.03 | < 0.001 | |||||
 Blood loss beyond 25 h postoperatively (ml) | 113.31 ± 108.77 | 111.64 ± 97.73 | 162.34 ± 176.69 | 0.096 | |||||
 Blood loss totality postoperatively (ml) | 801.7 ± 460.14 | 748.57 ± 409.53 | 1016.67 ± 529.08 | < 0.001 | |||||
 Major bleeding, n (%) | 52 (36.62%) | 42 (29.37%) | 66 (46.81%) | 0.010 | |||||
 Reoperation, n (%) | 1 (0.7%) | 0 (0%) | 6 (4.26%) | 0.011 | |||||
Allogenic transfusion | |||||||||
 Red blood cells (unit) | 2.57 ± 3.15 | 2.15 ± 2.7 | 3.73 ± 4.21 | 0.002 | |||||
 Plasma (unit) | 279.61 ± 439.44 | 172.03 ± 298.92 | 382.98 ± 530.49 | 0.002 | |||||
 Platelets (unit) | 0.01 ± 0.12 | 0.03 ± 0.2 | 0.06 ± 0.26 | 0.160 | |||||
Patients exposed to allogenic blood products | |||||||||
 Red blood cells, n (%) | 83 (58.45%) | 79 (55.24%) | 98 (69.50%) | 0.036 | |||||
 Plasma, n (%) | 61 (42.96%) | 49 (34.27%) | 71 (50.35%) | 0.023 | |||||
 Platelets, n (%) | 2 (1.41%) | 3 (2.10%) | 7 (4.96%) | 0.159 | |||||
 Any, n (%) | 97 (68.31%) | 87 (60.84%) | 104 (73.76%) | 0.065 | |||||
 | Ulinastatin vs. Tranexamic acid | Ulinastatin vs. Placebo | Tranexamic acid vs. Placebo | ||||||
 | RD (95%CI) or MD (95%CI) | RR (95%CI) | P. | RD (95%CI) or MD (95%CI) | RR (95%CI) | P | RD (95%CI) or MD (95%CI) | RR (95%CI) | P |
Bleeding | |||||||||
 Blood loss within 8 h postoperatively (ml) | 24.31 (−37.30,85.91) | – | 0.148 | −122.86 (−195.87,-49.86) | – | < 0.001 | − 147.17 (− 220.05,-74.30) | – | < 0.001 |
 Blood loss 9–16 h postoperatively (ml) | 18.66 (− 11.11,48.44) | – | 0.507 | −21.63 (−55.49,12.22) | – | 0.016 | −40.29 (−74.09,-6.50) | – | 0.001 |
 Blood loss 17–24 h postoperatively (ml) | 8.49 (−10.13,27.12) | – | 0.913 | −21.45 (−44.58,1.68) | – | 0.029 | −29.94 (−53.03,-6.85) | – | 0.020 |
 Blood loss within 24 h postoperatively (ml) | 51.46 (−37.47,140.40) |  | 0.257 | −165.95 (− 262.88,-69.01) |  | < 0.001 | − 217.41 (− 311.45,-123.37) |  | < 0.001 |
 Blood loss beyond 25 h postoperatively (ml) | 1.66 (−22.44,25.77) | – | 0.951 | −49.03 (−83.92,-14.15) | – | 0.060 | −50.70 (−85.52,-15.87) | – | 0.062 |
 Blood loss totality postoperatively (ml) | 53.13 (−48.42,154.68) | – | 0.463 | − 214.98 (−338.60,-91.36) | – | < 0.001 | − 268.11 (− 391.51,-144.70) | – | < 0.001 |
 Major bleeding (person) | 0.0725 (− 0.0364,0.181) | 1.25 (0.893,1.74) | 0.193 | − 0.102 (− 0.216,0.0124) | 0.782 (0.592,1.03) | 0.082 | − 0.174 (− 0.286,-0.0632) | 0.628 (0.460,0.855) | 0.002 |
 Reoperation (person) | 0.0070 (− 0.0067,0.0208) | 3.02 (0.124,73.5) | 0.315 | −0.0355 (− 0.0716,0.0005) | 0.166 (0.0202,1.36) | 0.055 | − 0.0426 (− 0.0759,-0.0092) | 0.0759 (0.0043,1.33) | 0.012 |
Allogenic transfusion | |||||||||
 Red blood cells (unit) | 0.42 (−0.26,1.10) | – | 0.330 | −1.16 (− 2.06,-0.26) | – | 0.016 | −1.58 (− 2.48,-0.69) | – | 0.001 |
 Plasma (unit) | 107.58 (20.00,195.16) | – | 0.052 | −103.37 (− 217.62,10.88) | – | 0.113 | − 210.95 (− 325.00,-96.90) | – | 0.001 |
 Platelets (unit) | − 0.01(− 0.05,0.02) | – | 0.656 | −0.04(− 0.10,0.011) | – | 0.088 | −0.03(− 0.08,0.02) | – | 0.195 |
Patients exposed to allogenic blood products | |||||||||
 Red blood cells (person) | 0.0321 (−0.0829,0.147) | 1.058 (0.864,1.30) | 0.585 | −0.111 (− 0.222,0.0006) | 0.841 (0.705,1.00) | 0.053 | −0.143 (− 0.254,-0.031) | 0.795 (0.662,0.955) | 0.013 |
 Plasma (person) | 0.0869 (−0.0257,0.200) | 1.254 (0.933,1.69) | 0.132 | −0.0740 (− 0.190,0.0420) | 0.853 (0.664,1.10) | 0.212 | −0.161 (− 0.274,-0.048) | 0.681 (0.514,0.900) | 0.006 |
 Platelets (person) | −0.0069 (− 0.0373,0.0236) | 0.671 (0.114,3.96) | 0.658 | −0.0356 (− 0.0763,0.0052) | 0.284 (0.0600,1.34) | 0.088 | − 0.0287 (− 0.0715,0.0142) | 0.423 (0.112,1.60) | 0.190 |
 Any (person) | 0.0747 (−0.0360,0.185) | 1.12 (0.945,1.34) | 0.187 | −0.0545 (− 0.160,0.0510) | 0.926 (0.798,1.08) | 0.312 | −0.129 (− 0.237,-0.0212) | 0.825 (0.700,0.972) | 0.020 |