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Table 1 A schematic of the study timeline including the standard protocol items as defined by the 2013 SPIRIT statement [23, 24]

From: C1 inhibitor in canine intravascular hemolysis (C1INCH): study protocol for a randomized controlled trial

 

Screening

Study period

Follow-up period

T0

Day 1

Day 2

Day 3

Day 4

Day 5

Discharge

Day 7

Day 14

Day 28

Enrollment

Eligibility screen

x

         

Informed consent

x

         

Randomization and allocation

 

x

        

Intervention

Standardized workup

 

x

x

x

      

Standardized therapy

 

x

x

x

x

x

 

x

x

x

Drug or placebo (q8h)

 

x, x, x

        

Assessment

Complete blood count

 

x

x

x

x

x

    

Serum chemistry (LDH, HI, Hb, bilirubin)

 

x

x

x

x

x

    

C5b-9 complex

 

x

x

x

x

x

    

Residual plasma complement

 

x

x

x

x

x

    

Serum haptoglobin concentration

 

x

x

x

x

x

    

Erythrocyte bound C3b

 

x

x

x

x

x

    

Duration of hospitalization

      

x

   

Red cell transfusion requirements

      

x

   

Rescue therapy requirements

      

x

   

Survival (Alive, died, euthanized)

      

x

x

x

x

Follow-up

Telephone follow-up

       

x

x

x