Fattouch 2007.

Study characteristics
Methods	Single‐centre prospective, randomised, placebo‐controlled, double‐blind study Run‐in period: between February 2003 and April 2006. Number of study centres and location: single centre. Unit of Cardiac Surgery, University of Palermo, Palermo, Italy.
Participants	Eighty patients affected with STEMI who underwent emergent CABG. Participants were assigned to two groups: C1‐INH group (38 participants) and placebo group (42 participants). Mean age: 59.9 years Gender (female/male ratio): 32.5% High‐risk population Inclusion criteria: STEMI and coronary artery reperfusion with CABG within 12 hours after the onset of symptoms or the ischaemic event, recurrent myocardial ischaemia refractory to medical therapy, no candidates for fibrinolytic or primary PTCA, primary PTCA failure with persistent symptoms or haemodynamic instability, life‐threatening ventricular arrhythmias in patients with left main stenosis or three‐vessels disease, and patients with multivessel or left main disease and haemodynamic instability Exclusion criteria: mechanical complications of MI; patients requiring cardiopulmonary resuscitation; onset of cardiac shock > 6 hours; concomitant cardiac surgical procedures; associated renal, hepatic, or pulmonary diseases; patients with known complement deficiency or immune deficiency syndrome, known autoimmune disease, or evidence of infection; and coagulation disorder
Interventions	Participants were assigned in two groups: C1‐INH group (received 500 IU as IV bolus 10 min before reperfusion (aortic unclamping) followed by an IV infusion of 500 UI for 3 hours after surgery) and placebo group (received a saline solution).
Outcomes	Primary outcomes: mortality and MI size or the extent of irreversible myocardial cell injury Secondary outcomes: the incidence of LCOS; IABP and CPB support; inotropic support; time of intubation; ICU LOS and hospital LOS; major bleeding, infection, and renal failure requiring temporary haemodialysis; mechanical ventilation support; complement inhibition; haemodynamic data (mean arterial blood pressure, cardiac index, stroke volume); C1‐INH, C3a, C4a complement activation fragments, and cTnI serum levels Data were measured before, during, and after surgery at six different times: T1 (before induction of anaesthesia); T2 (after heparin dose); T3 (10 min after drug administration); T4 (2 h post‐CPB); T5 (12 h post‐CPB); and T6 (24 h after surgery).
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The two groups did not differ in baseline characteristics, but there was no description of randomisation method.
Allocation concealment (selection bias)	Unclear risk	No information around allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Double‐blind study, no further description
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 ITT analysis. Data from all participants were included in the final analysis.
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported properly.
Other bias	Low risk	This work is supported by the Italian National Council of Research (CNR). No conflicts of interest were disclosed.