Primary end point |
Thrombelastograph (TEG®) functional fibrinogen (FF) maximum amplitude (MA) in millimetres at 15 min post intervention |
Secondary end points |
• TEG® FF MA in millimetres at 2, 6, 24 and 72 hours post intervention • TEG® MA in millimetres at 15 min, 2, 6, 24 and 72 hours post intervention • Transfusion requirements (red blood cells (RBC) or fresh frozen plasma (FFP) or platelets (PLT)) at 2, 6, 24, 72 hours and in total at day 30 • Total use of haemostatic therapy (i.e. use of coagulation factor concentrates and tranexamic acid) in the first 24 and 72 hours, omitted from this is active treatment (intervention) • Time to intervention or placebo • Time to FFP and PLT transfusion • Percentage of patients receiving intervention or placebo <1 hour of arrival • Time to surgical control of bleeding as noted by the surgeon • Severe adverse reactions at day 30, defined as symptomatic thromboembolism at day 30 and anaphylaxis at day 30 • 24-hour and 30-day mortality |