Table 3.
SPIRIT schedule with study process and data collection during study period
| Study period | ||||||
|---|---|---|---|---|---|---|
| Enrolment | Randomisation | Post randomisation | ||||
| Timepoint | -T | T = 0 | Hospitalisation | T < week 2 | T + 30 day | T + 1 year |
| Enrolment | ||||||
| Inclusion criteria | X | |||||
| Exclusion criteria | X | |||||
| Allocation | X | |||||
| Informed consent | X | X | ||||
| Interventions | ||||||
| Intervention or control group | X | |||||
| Assessments | ||||||
| ROSC | X | |||||
| Survival | X | X | X | X | X | |
| Pre-hospital registrations | ||||||
| Utstein styled documentation | X | X | ||||
| End-tidal CO2 | X | |||||
| REBOA-procedure related data | X | |||||
| All relevant dispatch/procedure times | X | X | X | |||
| In-hospital registrations | ||||||
| Blood gas from admission | X | |||||
| Blood sample analysis | X | X | ||||
| Urine output | X | X | ||||
| Complications related to REBOA | X | X | X | |||
| Cardiac interventions | X | X | X | |||
| Length of stay intensive care | X | X | X | |||
| Length of stay hospital | X | X | X | |||
| Length of invasive respiratory support | X | X | X | |||
| Length of renal replacement therapy | X | X | X | |||
| Modified Rankin scale | X | |||||
| Adverse events | X | X | X | X | ||
SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; ROSC, return of spontaneous circulation; REBOA, resuscitative endovascular balloon occlusion of the aorta