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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