Assessment of high-normal dosage of Wilate ® compared to placebo administered in combination with platelets to assess reduction of amount of blood loss, need of transfusion products and outcome (length of stay, mortality) in patients with bleeding in comparison.
Age ≥ 18 years
Admission to intensive care unit
Patients needing platelet transfusion during or after surgery with or without prior treatment with single or dual antiplatelet agents (ASS, Prasugrel, Clopidogrel, Ticagrelor)
Consent by the patient or a family member in addition to the consent of an independent ICU physician
Patients receiving Factor VIII concentrate before inclusion of the study (Haemate ®)
Women who are pregnant or breastfeeding
Participation in another study with an investigational drug within the 30 days preceding and during the present study
Overt Disseminated Intravascular Coagulation (DIC)
Parallel
Wilate
DrugWilate ® will be given with platelets in cases of severe bleeding. Wilate ® is a 1:1 balanced mixture of von Willebrand Factor (2'000 IU) and Coagulation factor VIII (2'000 IU) and as such has anti-haemorrhagic potential. It is extracted from plasma, freeze-dried and virus-inactivated.
Placebo
Other interventionEmpty placebo will be given with platelets in cases of severe bleeding.
Number of blood products
Number of blood products (fresh frozen plasma (FFP), red blood cells (RBC)) according to groups.
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