Greilich 2001.

Study characteristics
Methods	Randomised, double‐blind, placebo‐controlled study Run‐in period: not specified Study date: 2001 Number of study centres and locations: Number of centres not specified. Dallas Veterans Affairs Medical Center – the Department of Anesthesiology and Pain Management, the Department of Physiology, and the Department of Cardiovascular and Thoracic Surgery, University of Texas Southwestern Medical Center, Dallas
Participants	Seventy‐two participants undergoing CABG were randomly chosen to receive high‐dose aprotinin (n = 24), EACA (n = 23), or saline placebo (n = 25). Mean age: 62.98 years Sex (female/male ratio): not specified No high‐risk population Inclusion criteria: elective, primary CAB with ECC. Participants were not excluded from the study if they were receiving salicylates, nonsteroidal anti‐inflammatory drugs, or heparin before surgery. Exclusion criteria: corticosteroids, dipyridamole or anticoagulants, Plt or coagulation abnormalities, thrombolytic therapy within 5 days of surgery, Cr level > 2.0 mg/dL, EF < 30%, and a history of adverse reaction to aprotinin
Interventions	Intervention group: full‐dose aprotinin (2 × 106 KIU [load], 2 × 106 KIU [pump prime], 5 × 105 KIU/h [infusion]) Control group: saline (200 mL [load], 200 mL [pump prime], 50 mL/h [infusion])
Outcomes	IL‐10, IL‐6, and clinical outcomes (heart rate; mean arterial blood pressure; peripheral arterial saturation; CVP; mean pulmonary arterial pressure; pulmonary capillary wedge pressure; cardiac output; Hb, Hct, and Plt counts; fibrinogen concentration; WBC counts; mediastinal chest tube drainage; blood product administration; duration of postoperative mechanical ventilation; duration of inotropic support; and the length of the ICU stay) Blood samples were measured at five time points: baseline (before induction); 10 minutes of ECC; 30 minutes after ECC (after heparin reversal); 3 hours after ECC; and 18 hours after ECC.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	There were no significant differences between the participants, but no further randomisation method description.
Allocation concealment (selection bias)	Unclear risk	No allocation information
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind study
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not specified
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)	Unclear risk	Both clinical and inflammatory markers were not properly assessed (IL‐6 data not reported).
Other bias	Low risk	This study was funded by the Department of Veterans Affairs and by Research Starter Grants from the Society of Cardiovascular Anesthesiologists and Bayer Corporation.