Studies
Mean age
Type of surgery CPB time (min) Intervention Primary endpoints Jadad Score Ulinastatin Control Randomization Blinding Withdrawals
Mishima et al., 1990 [23 ] 20 57.8 CABG 155 163 Grp1: 5000 U/kg i.v. drip before CPB
) Grp 2: Placebo (
) ET, OI, PMNE 1 0 1
Sato et al., 2000 [31 ] 15 65 CABG, repair of VSD, ASD 155 191 Grp1: 600,000 U into priming solution, 300,000 U i.v. drip before removal of aortic clamping, 150,000 U i.v. drip Bid for 5 days (
) Grp 2: blank (
) Complication rate, IL-6, IL-8, PMNE 2 1 1
Ren et al., 2003 [24 ] 20 6.7 repair of VSD, ASD Not stated Grp1: 6000 U/kg into priming fluid and 6000 U/kg i.v. before aorta cannulation (
) Grp2: Placebo (
) Complication rate, cTnI, CKMB 1 1 1
Wang et al., 2005 [26 ] 30 35.9 valve surgery 68.2 82.1 Grp1: 10,000 U/kg into primary solution and 10,000 U/kg i.v. before CPB (
) Grp2: Placebo (
) Complication rate, OI, TNF-
, PMNE 1 0 1
Nakanishi et al., 2006 [29 ] 30 62 CABG 150 135 Grp1: 5000 U/kg i.v. before aortic cannulation (
) Grp 2: Placebo (
) Complication rate, ICU stay, OI, CI, ET, cTnI, CKMB, IL-6, IL-8 2 2 1
Bingyang et al., 2007 [30 ] 30 57.4 CABG 108 117 Grp1: 300,000 U i.v. before CPB, 300,000 U i.v. before aortic clamping release, 400,000 U i.v. after protamine (
) Grp 2: Placebo (
) Complication rate, ICU stay, ET, PMNE, IL-8, TNF-
, IL-6 1 0 1
Wang et al., 2007 [25 ] 24 57 CABG No CPB Grp 1: 6000 U/kg i.v. after induction of anesthesia and 1000 U·kg−1 ·h−1 i.v. to the end of operation (
) Grp 2: Placebo (
) ET, cTnI 2 2 0
Li et al., 2007 [34 ] 24 52.5 valve surgery 91.3 97.2 Grp 1: 50,000 U/kg i.v. Q 12 h for postop. 3 days (
) Grp 2: Placebo (
) ICU stay, ET, OI, CI, IL-6, IL-8, TNF-
2 0 1
Jiang et al., 2008 [22 ] 58 3.3 repair of VSD and ASD 52 58 Grp 1: 20,000 U/kg into the prime solution (
) Grp 2: Placebo (
) ICU stay, ET, OI, IL-6, IL-8, TNF-
2 0 1
Song et al., 2011 [33 ] 48 54 valve surgery 170 172 Grp1: 5000 U/kg i.v. before aortic cross clamping (
) Grp 2: Placebo (
) Complication rate, ICU stay, ET, cTnI, CKMB 2 2 1
Tu and Ming 2011 [32 ] 30 3.6 repair of VSD and ASD 76 70 Grp1: 5000 U/kg i.v. drip Tid for 3 days (
) Grp2: blank (
) Hospital mortality, complication rate, IL-6, TNF-
, cTnI 2 0 1
Zhang and Qin 2012 [27 ] 60 62.8 CABG, 98 95 Grp1: 150,000 U i.v. drip after induction of anesthesia and 150,000 U i.v. drip after CPB (
) Grp 2: Placebo (
) Hospital mortality, complication rate, ICU stay, ET, CKMB, cTnI 2 1 1
Oh et al., 2012 [28 ] 60 67 valve surgery 99 96 Grp1: 300,000 U i.v. drip after induction of anesthesia, 400,000 U into CPB prime solution, and 300,000 U after weaning from CPB (
) Grp 2: Placebo (
) ICU stay, ET, CKMB, CI 2 2 1
Chong et al., 2013 [36 ] 36 54.8 aortic arch replacement 235.5 247.2 Grp1: 20,000 U/kg i.v. drip in total: 1/3 after anesthesia induction, 1/3 before aortic cross-clamp, and 1/3 after aortic clamp release (
) Grp 2: Placebo (
) Hospital mortality, complication rate, ICU stay, ET, IL-6, IL8, PMNE, TNF-
2 2 0
Song et al., 2013 [35 ] 24 58 valve repair 150 139 Grp1: 5,000 U/kg i.v. drip after the opening of a pericardium (
) Grp 2: Placebo (
) ET, OI, CI, cTnI, CKMB, IL-6, TNF-
2 2 1
CABG: coronary artery bypass graft, VSD: ventricular septal defect, ASD: atrial septal defect, CPB: cardiopulmonary bypass, UTI: urinary trypsin inhibitor, Grp: group, postop.: postoperative, Bid: twice a day, Tid: three times a day, i.v.: intravenous, ET: extubation time, OI: oxygenation index, PMNE: polymorphonuclear neutrophil elastase, IL-6: interleukin-6, IL-8: interleukin-8, cTnI: cardiac troponin-I, CK-MB: creatine kinase MB isoenzyme, TNF-
: tumor necrosis factor-alpha, CI: cardiac index. 