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Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) table for the SVPE safety and feasibility study

From: Small volume plasma exchange for Guillain-Barré syndrome in resource poor settings: a safety and feasibility study

  Study period
  Enrolment Allocation Post-allocation Close-out
  Entrya 0 Day 1–3 Day 4 Day 5–8 Day 10 Discharge* Day 30*
Time point
 Eligibility screen +        
 Informed consent +        
 Allocation   +       
Interventions
 SVPE    + + +    
 Non-SVPE    + + +    
Assessments
 SVPE procedureb    + + +    
 Hemodynamicc + + + + + + +  
 Biochemistryd + ±‡ ±‡ + ±‡ +   
 Infection screeninge + ±‡ ±‡ + ±‡ +   +
 Neurologicalf + +   +   + + +
  1. *For patients treated with SVPE. ‡ Assessed as per indication
  2. aWithin 14 days of onset of muscle weakness
  3. bNumber and duration of each SVPE session and volume of the plasma removed and the replacement fluid infused
  4. cBlood pressure, heart rate, body temperature, and pulse oximetry
  5. dHemoglobin (g/L), coagulation profile, serum level of calcium, magnesium, albumin, renal, and liver function test
  6. eComplete blood count, erythrocyte sedimentation rate (ESR), C-reactive protein, and microbiological investigations to assess CLABSI, CAUTI, and VAP
  7. fGBS disability score and MRC sum score