McMichan 1982.

Methods	Randomised controlled trial.
Participants	77 patients with a combination of hypovolaemic shock and major fractures of the lower limb and or pelvis. Patients seen 12 or more hours after injury and those with major head or chest injuries were excluded. Age was reported by group (intervention = 30.9 +/‐ 18.4; placebo = 36.2 +/‐ 20.2).
Interventions	Aprotinin group: 500,000 Kallikrein Inhibitor Units (KIU) IV statim (immediately) followed by 300,000 KIU at 6‐hour intervals for 96 hours. Setting: Alfred Hospital, Melbourne, Australia
Outcomes	Death. Mean blood transfusion. Respiratory function.
Notes	It was noted in the results that the data on transfusion requirement was found to have a non‐normal distrubution. Nevertheless, the mean and standard deviation were presented.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described.
Allocation concealment (selection bias)	Low risk	"The placebo was supplied in similar ampoules...All ampoules were in boxes of 50, with a code number assigned to each box." (pg 108)
Blinding of participants and personnel (performance bias) Death, vascular occlusive events, intracranial bleeding	Low risk	"The nature of the contents of ampoules was not known to any of the investigators nor to any of the attending physicians. The codes were not broken until the conclusion of the study". (pg 108)
Blinding of participants and personnel (performance bias) Surgical intervention, blood transfusion	Unclear risk	"The nature of the contents of ampoules was not known to any of the investigators nor to any of the attending physicians. The codes were not broken until the conclusion of the study". (pg 108)
Blinding of outcome assessment (detection bias) Death, surgical intervention, blood transfusion	Low risk	"The nature of the contents of ampoules was not known to any of the investigators nor to any of the attending physicians. The codes were not broken until the conclusion of the study". (pg 108)
Blinding of outcome assessment (detection bias) Vascular occlusive events, intracranial bleeding	Unclear risk	Data on these outcomes were not reported.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Reported that 7 patients were excluded. 3 died within first 24 hours, 1 was transferred to a specialist hospital and died 1 week later, 3 patients refused to continue participation in the trial. The group to which these excluded patients were allocated is not reported, but it is stated that "[t]he 7 excluded patients provided no bias for or against either treatment group". (pg 109)
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgement.