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Table 1 Flow Chart COBBANA Trial.

From: A randomized, controlled, prospective trial to evaluate the haemostatic effect of Lyostypt versus Surgicel in arterial bypass anastomosis: "COBBANA" trial

  Visit 1 (Screening) Visit 2 (OP) Visit 3 (2 ± 1 days post OP) Visit 4 (Day of discharge) Visit 5 (30 ± 10 Days post OP)
Patient information X     
Informed consent X     
Demographic data* X     
Smoker/non-smoker X     
Inclusion/exclusion X     
Past medical history X     
Physical examination X X X 1) X 1) X 1)
Surgery   X    
Time to obtain hemostasis   X    
Deviation from surgical procedures as described in the protocol   X    
Number of used devices   X    
Intraoperative handling of the devices   X    
Recurrence of bleeding   X X X x
Adverse Event/Serious Adverse Event   X X X X
Local and general complication/re-operation   X X X X
Mortality      X
  1. * date of birth, gender, weight, height,
  2. 1) of the operational wound