Table 2 Classification of primary and secondary outcomes

Binary outcome measures

• Primary outcome measure: proportion of patients experiencing an infectious or ischaemic event

The following secondary outcome measures:

• Proportion of patients experiencing an infectious event

• Proportion of patients experiencing an ischaemic event

• Use of activated factor seven

• Use of Human Blood Coagulation Factor IX

• Significant pulmonary morbidity

Continuous outcome measures

The following secondary outcome measures:

• Units of RBCs transfused

• Fresh frozen plasma transfusions

• Cryoprecipitate transfusions

• Platelet transfusions

Time-to-event outcome measures

The following secondary outcome measures:

• Time from randomization to first occurrence of the primary outcome measure (secondary analysis of the primary outcome measure)

• Duration of post-randomization stay in intensive care or high dependency unit

• Duration of post-randomization hospital stay

• Time from randomization to death from any cause

Continuous longitudinal outcome measures

The following secondary outcome measures:

• EQ5D single summary index score

• EQ5D visual analogue scale score