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

From: Treatment of voluminous and complicated superficial slow-flow vascular malformations with sirolimus (PERFORMUS): protocol for a multicenter phase 2 trial with a randomized observational-phase design

  Screening Inclusion Switch (start sirolimus) Switch + M1 ± 15 days Follow-up during sirolimus treatment: every 2 months ±15 days End of study
J-30/J0* J0 Between month 4 and 8** Between month 5 and 9** Between month 7 and 11** Month 12***
Information x x     
Inclusion/exclusion criteria x x x x x  
Medical history and demographics x x     
Consent   x     
Randomization   x     
MRI x1   x    x
Physical examination   x x x x x
General laboratory tests   x2 x3 x4 x4  
Coagulation markers, serum VEGF, tissue factor   x   x x x
Serum level of sirolimus adjustments5     x x  
Blood and skin samples for genetic analysis and collection (ancillary study)   x     
Photographs   x x    x
Self-assessment for patients and proxy by visual analog scale    x x x x
Dermatological quality of life scale   x x x x x
Adverse events/serious adverse events6     x x x
  1. *possibly by call phone
  2. **depending on the date of the treatment switch from observational to treatment stage
  3. ***sirolimus might be maintained at the discretion of investigators after the protocol is finished
  4. 1included in routine care
  5. 2complete blood count, ionogram, creatinine, urea, liver enzymes (gamma-GT, SGOT, SGPT), cholesterol, triglycerides, glucose, infection with HIV and hepatitis B and C, serum β-hCG or urine pregnancy test for women of childbearing age
  6. 3complete blood count, ionogram, creatinine, urea, liver enzymes, cholesterol, triglycerides, glucose, urinary pregnancy test on women of childbearing age
  7. 4every month during sirolimus: complete blood count, ionogram, creatinine, urea, liver enzymes, cholesterol, triglycerides, glucose
  8. 5performed after 15 days of sirolimus and then once a month
  9. 6adverse events will be recorded from when the informed consent form is signed
  10. VEGF vascular endothelial growth factor