This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
208
120 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 120 mcg/kg single bolus administration at completion of wound closure
60 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 60 mcg/kg single bolus administration at completion of wound closure
Trial drug into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. Single bolus administration at completion of wound closure
Novo Nordisk Investigational Site
Camperdown, Australia
Novo Nordisk Investigational Site
Heidelberg, Australia
Total number of RBC units transfused during the perioperative period
Number of RBC units transfused by surgical phase
Adverse events
Changes in coagulation related parameters
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Novo Nordisk Investigational Site
Vancouver, British Columbia, Canada
Novo Nordisk Investigational Site
London, Canada
Novo Nordisk Investigational Site
Québec, Canada
Novo Nordisk Investigational Site
Toronto, Canada
Novo Nordisk Investigational Site
Clichy, France
Novo Nordisk Investigational Site
Berlin, Germany
Novo Nordisk Investigational Site
Essen, Germany
Novo Nordisk Investigational Site
Barakaldo, Spain
...and 8 more locations