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Table 2 Trial end points

From: Pilot Randomized trial of Fibrinogen in Trauma Haemorrhage (PRooF-iTH): study protocol for a randomized controlled trial

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