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. 2023 Oct 24;2023(10):CD013584. doi: 10.1002/14651858.CD013584.pub2

Pang 2016.

Study characteristics
Methods Prospective, randomised study
Run‐in period: between January 2012 and June 2014
Study date: 2016
Number of study centres and locations: single centre. Department of Cardiac Surgery, Qilu Hospital of Shandong University, Shandong, China
Participants The study included 60 participants undergoing CPB who were randomly divided into a UTL group (n = 30) and a control group (n = 30).
Mean age: 51.85 years
Sex (female/male ratio): 40%
No high‐risk patients
Inclusion criteria: participants underwent CPB for CABG surgery, valve replacement, or combined operation.
Exclusion criteria:

  1. previous cardiac surgery;

  2. severely impaired liver or kidney function;

  3. allergies; and

  4. pregnant and breastfeeding women.
Interventions Intervention group: UST, 5000 U/kg UTL (Guangdong Tianpu Biochemical MEDICINE Co, Ltd, 12,000 U/teams, batch number: 20040505) intravenously in 50 mL normal saline for 20 minutes after the induction of anaesthesia, heparin, and protamine, respectively
Control group: similar volumes of normal saline and similar timing
Outcomes Perioperative inflammatory response (WBC count, IL‐2, IL‐8, IL‐6, TNF‐α, neutrophil elastin) and pulmonary function (PA‐aDO2, RI, PaO2, FiO2, oxygenation index, tidal volume, peak airway pressure, plateau airway pressure, PEEP, pulmonary Cd, and pulmonary Cs), PBMC apoptosis, TLR4 and HSP70 expressions, and clinical data (operation time, heart resuscitation, duration of postoperative mechanical ventilation, length of ICU stay, time of drainage tube usage, and postoperative hospitalisation length of stay)
Blood samples were drawn through the internal jugular vein after anaesthetic induction (T1), immediately after aortic valve opening (T2), and 4 hours (T3) and 24 hours (T4) after weaning from CPB.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No randomisation method described; however, no significant differences in baseline characteristics between groups
Allocation concealment (selection bias) Unclear risk No allocation concealment information
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No mention of blinding of participants and personnel
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No mention of blinding of outcome assessment
Incomplete outcome data (attrition bias)
All outcomes Low risk No trial group changes, no withdrawals, and no losses to follow‐up were reported, but no intention‐to‐treat analysis. Data from all the participants were included in the final analysis.
Selective reporting (reporting bias) Low risk All expected outcomes were reported properly.
Other bias Low risk The authors had no conflicts of interest to declare.