Table 3 Trial schedule (investigations)
Trial assessment | Enrolment | Days between enrolment and randomisation | Day R Day of randomisation platelet count ≤50 × 109/L | Days between Day R and study day 1 | Day 1 | Day 2 | Days 3–11 | Day 12 (± 2) | Days 13–29 | Day 30 (± 2) |
|---|---|---|---|---|---|---|---|---|---|---|
Pregnancy test (if applicable) | X | |||||||||
Urine dipstick | X | |||||||||
Haemoglobin | X | X | X | X | X | X | X | X | ||
Platelet count | X | X | X | X | X | X | X | X | X | X |
Prothrombin time (or INR if PT not available) | X | X | ||||||||
Serum creatinine (U&E) | X | X | X | X | Three times a week or as SOC | X | Three times a week or as SOC | X | ||
Liver function tests: bilirubin and albumin | X | X | Required if VOD is reported/suspected 3 times a week | Required if VOD is reported/suspected 3 times a week | ||||||
HLA antibody screen† | X | |||||||||
INVESTIGATIONS TO BE PERFORMED ONLY AT SELECTED PARTICIPATING CENTRES | ||||||||||
Assays for fibrinolysis | X | X | X | Required three times a week | ||||||