Table 2 Baseline data assessed upon study inclusion (data prior/upon admission to ICU) to be documented before administration of the study drug

Informed consent or statement of an independent physician

X

Randomisation, assignment of the group

X

Demographics^a

X

Admission diagnosis

X

Past medical history

X

Relevant medication prior to bleeding (1 month)^b

X

Type of admission (medical, surgical)

X

SAPS II

X

SOFA score

X

Type of surgery (if applicable)

X

Cause of bleeding

X

Reason for thrombocyte transfusion

X

Amount of blood loss prior to ICU admission

X

Vital parameters^c

X

Lowest temperature measured^d

X

Lowest temperature measured

Fluid balance^e

X

Full blood count and chemogram^f

X

Coagulation laboratory^g

X

Platelets function analysis (VerifyNow® ADP test) before administration of the study drug

X

Number of given RBCs

X

Number of given FFPs

X

Number of given platelet concentrates

X

Amount of prothromblex

X

Amount of tranexamic acid

X

Amount of fibrinogen

X

Name/amount of other given coagulation products^h

X

Transfusion-related side effects (AE, SAE)

X

Thromboembolic events

X