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Table 2 Study flow chart – laboratory assessments

From: Intravenous immunoglobulin therapy for small fiber neuropathy: study protocol for a randomized controlled trial

  Screening Treatment phase End of Treatment Follow-up5
Lab assessment - 10 days (Day -10 to Day 0) Week 0 Baseline/ Day 1 Completion of baseline
infusion
(Day 2 or 3 or 4)
3-6 Days after completion of baseline infusion Week 3,6,9
(± 3 days)
Week 12 (± 3 days) Month 4, 5, 6
Immunofixation X       
Pregnancy Test (Serum β HCG) X       
TSH1 / regular T4 X       
Fasting blood glucose, vitamin B122 X       
Serum Retain3 X      X  
Urinalysis X    X    
IgG4   X X4 X X X  
Hematology/CBC (hematocrit, hemoglobin, WBC, RBC, platelets) X X   X X X  
Creatinine, Blood urea nitrogen X X   X X X  
AST/ALT, LDH, potassium, bilirubin, CK   X X4   X X  
Gamma-GT   X X4 X   X  
  1. 1 TSH to be conducted at screening if results not available since SFN diagnosis. Regular T4 automatically run by LabCorp if TSH determined to be above the upper limits of normal
  2. 2 To be conducted at screening if results not available since SFN diagnosis
  3. 3 2 aliquots required at screening (one for viral retain and one for possible future antibody testing); 1 aliquot required at both Week 12 (for possible future antibody testing)
  4. 4 Samples to be obtained immediately after completion of entire baseline infusion. If the entire baseline infusion is completed in 2 days, then samples are to be collected post-infusion on Day 2. If the entire baseline infusion is completed in 3 or 4 days, then samples are to be collected post-infusion on Day 3 or 4 respectively
  5. 5 The follow-up period will be performed by standardized telephone call interviews