Schedule of enrolment, interventions and assessments
| Timepoint | Pre-study | Study period | |||
| Delivery | Post-intervention, pre-discharge | Follow-up | |||
| 0 | 0–28 days | Consent* to 28 days | 3 months | ||
| Enrolment | |||||
| Allocation (cluster randomisation) | X | ||||
| Eligibility screen | X | ||||
| Informed consent | X | ||||
| Interventions | |||||
| Intervention clusters: 2 pools of early cryoprecipitate | X | ||||
| Standard haemorrhage protocol | X | ||||
| Assessments | |||||
| Demographics and medical history | X | ||||
| Documentation of medical and surgical interventions | X | ||||
| Clinical outcomes and adverse events | X | ||||
| Symptomatic thrombotic events | X | X | |||
| Haemostatic markers | X | ||||
| MFI questionnaire | X | ||||
| Qualitative interviews | X | ||||
*Alternatively, if conditions for waiver are fulfilled, routine data can be collected in the absence of written informed consent.
MFI, multidimensional fatigue inventory.