Skip to main content

Table 1 Flow-Chart: Overview Clinical Trial Study Activities

From: Comparison of the collagen haemostat Sangustop® versus a carrier-bound fibrin sealant during liver resection; ESSCALIVER-Study

Visit

1

Screening

2

Surgery

3

Follow-up

24 hrs after surgery

4

Follow-up

7 days after surgery

5

Follow-up

30 after surgery

6

Follow-up

3 months after surgery

Informed consent

x

     

Demographics

x

     

Medical history

x

     

Medication history

x

     

Physical examination

x

     

Blood and urine examinations

X1, 4

X1

X1

   

Eligibility Criteria

X2

X3

    

Randomisation

 

X

    

Liver resection (Resection area, weight, histopathology, prim. haemostasis)

 

X

    

Investigational treatment

 

Sangustop®/Tachosil®

    

Number of Sangustop® Compresses/Tachosil® Sponges used

 

X

    

Time to haemostasis

 

X

    

Required blood transfusions

   

X

  

Central venous pressure

 

X

    

Adverse events incl. complications

 

X

X

X

X

X

  1. 1Blood: INR, PTT, Hb, Ht; 21st part; 32nd part, 4Blood or urine: pregnancy test.