Skip to main content

Table 5 Schedule of assessments

From: Multi-centre, randomised, open-label, blinded endpoint assessed, trial of corticosteroids plus intravenous immunoglobulin (IVIG) and aspirin, versus IVIG and aspirin for prevention of coronary artery aneurysms (CAA) in Kawasaki disease (KD): the KD CAA prevention (KD-CAAP) trial protocol

 

Screening

D0*

D1

D2

D3

D4

D5

W1

W2

W6

W12

Unscheduled visit

Patient information sheet

X

           

Assessment of eligibility criteria

X

           

Informed consent (including for sample storage and genetic tests)

X

           

Randomisation

 

X

          

History & physical examination, vital signs [1]

X

X

X

X

X

X

X

X

X

X

X

X

Haematology [2]

[X]

Xb

[X]

X

[X]

[X]

X

[X]

X

X

[X]

[X]

C-reactive protein

[X]

Xb

X

X

X

X

X

X

X

X

[X]

[X]

Biochemistry [3]

[X]

Xb

[X]

X

[X]

[X]

X

[X]

X

X

[X]

[X]

Urinalysis [4]

[X]a

Xb

[X]

X

  

X

X

X

X

X

 

ECG

[X]

[X]

[X]

[X]

[X]

[X]

[X]

X

X

X

X

[X]

Echocardiography [5]

[X]a

[X]

[X]

[X]

[X]

[X]

[X]

X

X

X

X

[X]

Concomitant drugs & trial treatment

 

X

X

X

X

X

X

X

X

X

X

 

Health-related Quality of Life and resource utilisation [6]

 

X

     

X

X

X

X

 

Quality of Life [7]

 

X

        

X

 

pGTI

       

X

  

X

 

Pregnancy test [8]

X

         

X

 

Research samples to be stored (scientific substudies):

 - Plasma serum storage (0.5–1 ml EDTA and 0.5–1 ml serum)

 

X

 

X

  

X

 

X

X

  

 - EDTA blood for DNA storage (0.5–1 ml)

 

X

          

 - RNA pax gene tube for RNA extraction (2–2.5 ml)

 

X

 

X

  

X

 

X

   

 - Throat swab

 

X

          

Maximum total blood draw for research samples (ml)

 

5.5

0

4.5

0

0

4.5

0

4.5

2

0

0

  1. Randomisation occurs on day 0 (D0)
  2. aMicroscopy of urine for white cell count and echocardiography are only mandated at screening if required as inclusion criterion for incomplete KD
  3. bDo not need to be repeated at randomisation if values are available on the day of randomisation or the day before randomisation from routine tests
  4. [] indicates test not mandatory for the trial but results will be collected if available from routine care
  5. [1] Including vital signs (temperature, heart rate, blood pressure (BP), adverse events. Height (or length in young children) will be assessed at D0, W1, W2, W6 and W12. For children still febrile and in hospital on D5 daily maximum temperatures will be collected until discharge or until afebrile for 2 calendar days to allow assessment of the secondary endpoint ‘duration of fever after enrolment’. Weight will be assessed at D0, W6 and W12
  6. [2] Haematology: Hb, MCV, WCC, lymphocytes, neutrophils, platelets, erythrocyte sedimentation rate (ESR)
  7. [3] Biochemistry: urea, creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, sodium, potassium, albumin, calcium, phosphate, glucose, alkaline phosphatase (ALP), lactate dehydrogenase (LDH)
  8. [4] Urinalysis for proteinuria, haematuria, glycosuria
  9. [5] Echocardiography baseline scan is not required for eligibility
  10. [6] Child Health Utility 9D (CHU9D) questionnaire and EQ-5D-Y (youth version), depending on age, see Table 6 and if questionnaires are available in respective countries language. Should be completed at least one of W1 or W2 depending discharge. Resource utilisation will not be collected at baseline
  11. [7] Paediatric quality of life (PedsQL™)
  12. [8] Urine or blood pregnancy test must be completed for adolescents who have begun menstruation
Back to article page

Trials

ISSN: 1745-6215