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Table 3 Observations and blood sampling

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

   Time point
Day Day 1 Day 1 Day 1 Day 1 Day 2 Day 4 Day 30 (follow-up)
Hours 0 hrs baseline (before infusion) 15 min 2 hrs 6 hrs 24 hrs 72 hrs  
Informed consent X       
Demographics/medical history      X X X
Weight X       
Clinical parametersa X X X X X X  
Co-medicationb, incl. fluids/blood X X X X X X  
Haematology/biochemistry X X X X X X  
Thrombelastography X X X X X X  
Drug/placebo administration X       
Serious adverse events        X
Mortality      X   X
  1. Time points are calculated from infusion of study drug
  2. aClinical parameters including lactate, blood pressure and pulse
  3. bOnly concomitant medication affecting the haemostasis are registered