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Table 1 Schedule of visits, data collection and follow-up

From: INFERR-Iron infusion in haemodialysis study: INtravenous iron polymaltose for First Nations Australian patients with high FERRitin levels on haemodialysis—a protocol for a prospective open-label blinded endpoint randomised controlled trial

Visit day

Pre-screen

Day 1 baseline

3 M

6 M

9 M

12 M

15 M

18 M

21 M

24 M

27 M

30 M

33 M

36 M

Visit Window

  

± 2 weeks

± 2 weeks

± 2 weeks

± 2 weeks

± 2 weeks

± 2 weeks

± 2 weeks

± 2 weeks

± 2 weeks

± 2 weeks

± 2 weeks

± 2 weeks

Check eligibility

x

x

            

Informed consent

 

x

            

Demographic data

 

x

            

Medical history

 

x

            

Dialysis history

 

x

            

Sociodemographic history

 

x

            

Randomise

 

x

            

Blood test results1

x

x

x

x

x

x

x

x

x

x

x

x

x

x

Additional iron studies pathology2, 3

 

x

x

      

x

    

MRI scan (FerriScan)3

   

x

     

x

    

Ultrasound/FibroScan of the liver 4

   

x

     

x

    

Clinical outcomes data collection

  

x

x

x

x

x

x

x

x

x

x

x

x

Vital status (alive)

 

x

x

x

x

x

x

x

x

x

x

x

x

x

Procedures

 

x

x

x

x

x

x

x

x

x

x

x

x

x

Hospitalisations

 

x

x

x

x

x

x

x

x

x

x

x

x

x

Concomitant medication

 

x

x

x

x

x

x

x

x

x

x

x

x

x

Adverse events

 

x

x

x

x

x

x

x

x

x

x

x

x

x

  1. 1 Monthly routine blood test results will be reviewed at all scheduled study time points
  2. 2FBC, Retics, CYTOK, ADIPO, STFR and HPCD
  3. 3MRI (FerriScan) will occur within 6 months of randomisation and again between 12 and 18 months from day 1 on approx. 100 willing participants
  4. 4Ultrasound (FibroScan) will occur within 6 months of randomisation and again between 12 and 18 months from day 1
  5. 5A comparison of ferritin assays will be performed at 1 month post randomisation on a small number of participants