The duration of protocol during transfusion is two hours. Either adequate haemostasis will have been achieved by the interventions as indicated in the protocol or the scenario of inadequate haemostasis despite two administrations of standardising coagulation factor and trial medications followed by open label administration of rVIIa will have evolved. If this is the case, ongoing transfusion, surgical and medical management will be at the discretion of medical staff. Administration of rVIIa can be considered after discussion with trial investigators. Data will still be collected for such patients.