Table 3 ICU follow-up data to be assessed within the 48-hour study period beginning at study drug administration

Administration of study medication (or placebo)

Platelet function analysis (VerifyNow® ADP test) 30–60 min after administration of study drug

X

Check if informed consent is possible

X

Amount of blood loss since drug administration

X

Cause of bleeding (if occurred)

X

SOFA score

X

Vital parameters^a

X

Lowest temperature measured^b

X

Acidosis occurred (pH < 7.35)

X

 Duration of acidosis

X

Full blood count^c

X

Coagulation laboratory^d

X

ROTEM

X

Level of vWF and FVIII

X

Haemoglobin concentration

X

Fluid balance^e

X

Number of given RBCs

X

Number of given FFPs

X

Number of given platelet concentrates

X

Amount of Prothromblex after study intervention

X

Amount of tranexam acid after study intervention

X

Amount of fibrinogen after study intervention

X

Name/amount of other given coagulation products^f

X

Number of revision surgery for haemorrhage control

X

Transfusion-related side effects (AE, SAE, see 3.7)^g

X

Thromboembolic events

X

Any recurrent bleeding such as cerebral haemorrhage, DIC

X