Schedule of activities
| Type of visit | Screening | Enrolment | Randomisation | Week 1 | Week 2 | Week 3 | Week 4 |
|---|---|---|---|---|---|---|---|
| Screening | |||||||
| Timing of visit | Pre-ASCT* | Day 0 | |||||
| Confirm eligibility criteria | X | x | x | ||||
| Informed consent | X | ||||||
| Baseline characteristics | |||||||
| Demographic data | x | ||||||
| Disease, treatment history | x | ||||||
| ECOG and Karnofsky performance status | x | ||||||
| Comorbidities | x | ||||||
| Bleeding history | x | ||||||
| Bleeding assessment (WHO and BSMS) | x | ||||||
| Interventions† | |||||||
| Daily oral tranexamic acid‡ or prophylactic platelets§ | x | x | X | x | |||
| Assessments | |||||||
| Complete blood count¶ | x | x | x | x | x | ||
| Daily bleeding assessments (WHO and BSMS)† | x | x | x | x | x | ||
| Bearman toxicity scale | x | ||||||
| Daily NCI Toxicity Criteria Assessment for SAEs and AEs | x | x | x | x | |||
| Quality of life assessments** | |||||||
| FACT-BMT | x | x | x | x | x | ||
| FACT-Thrombocytopenia 18 | x | x | x | x | x | ||
| EQ-5D | x | x | x | x | x | ||
| GAD-7 | x | x | x | x | x | ||
*The enrolment visit should occur within 14 days prior to start of conditioning chemotherapy.
†From day 0 until platelet engraftment or day 30, whichever occurs first.
‡From first day with platelet count <50×109/L until platelet engraftment or day 30, whichever occurs first.
§Prophylactic platelets to be prescribed as per institutional practice.
¶Daily or as per institutional policy.
**Quality of life assessments to be performed once a week ±2 days.
AE, adverse event; ASCT, autologous haematopoietic stem cell transplantations; BSMS, Bleeding Severity Measurement Scale; ECOG, Eastern Cooperative Oncology Group; SAE, serious adverse event.