Evaluation of efficacy by determination of transfusion requirements and safety by determination of adverse events in administration of Von Willebrand factor concentrate F VIII (Haemate).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
intravenous infusion of Haemate (dosage dependent on body weight)
intravenous infusion of 0.9%NaCl-Solution
Klinik für Kardiovaskuläre Chirurgie
Düsseldorf, Germany
intra- and postoperative transfusion requirements of packed red cells, platelet concentrates and fresh frozen plasma according to defined transfusion thresholds
Time frame: begin of surgery and 48h after administration of medication
Assessment of adverse events and viral safety
Time frame: 1.perioperative 2. during hospital admission 3. within 90 days after surgery
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