Schedule of assessments
| Time points* Study procedures | D 0–2 | D 1–3 (12–24 post-dose) | Ongoing assessment (Alternate days)† (+/−1) | D 7 (+/−1) | Discharge (−2) | D 28 (−6/+2) | D 90 (+/−14) | D 180 (+/−28) |
| Consent | X | |||||||
| Inclusion/exclusion | X | |||||||
| WFNS grading | X | |||||||
| IMP treatment | X | |||||||
| Safety bloods‡ | X | X | X | X | X | X | ||
| Safety urine | X | X | X | X | ||||
| Lipid profile Coagulation screen | X | X | X | X | ||||
| TCD readings§ | X | X | X | |||||
| Hp, MDA (blood/CSF)¶ | X | X | X | |||||
| SFN and metabolites (blood/CSF)** | X | |||||||
| Pregnancy test | X | |||||||
| mRS | X | X | X | X | X | |||
| GOSE | X | X | X | |||||
| SAHOT | X | X | X | |||||
| SF-36 | X | X | X | |||||
| BICRO-39 | X | X | ||||||
| CLCE-24 | X | X | ||||||
| MRI | X |
*Ictus is defined as the onset of symptoms/haemorrhage and is referred to as day 0.
†These assessments will be done on every other day basis with a +/− 1 day window. They will be carried on until discharge or up to when it is clinically required.
‡Safety bloods include: biochemistry: sodium, potassium, urea, creatinine, glucose, calcium, total bilirubin, alkaline phosphatase, alanine transaminase, albumin, C-reactive protein, and haematology including haemoglobin, white blood cell count, neutrophils (absolute), lymphocytes (absolute), platelets. These will be done at least on alternate days until no longer clinically indicated.
§TCDs will be performed at baseline before day 3 and will be repeated on alternate daily basis until at least day 7 or where clinically indicated.
¶Hp and MDA will be assayed in both CSF and blood at baseline, where possible, that is, if patient has an EVD fitted this will be measured in the CSF and blood at baseline as well as every other day until EVD is removed. All patients will have Hp and MDA assayed on either a LP or EVD sample on day 7.
**SFN and its metabolites will be measured on day 7 in all patient with paired blood and CSF (LP or EVD sample).
BICRO-39, Brain Injury Community Rehabilitation Outcome Scales; CLCE-24, Check List for Cognitive and Emotional consequences following stroke; CSF, cerebrospinal fluid; EVD, external ventricular drain; GOSE, Glasgow Outcome Score ; Hp, haptoglobin ; IMP, investigational medicinal product; LP, lumbar puncture; MDA, malondialdehyde; mRS, modified Rankin Scale; SAHOT, Subarachnoid Haemorrhage Outcome Tool; SF-36, Short Form-36; SFN, sulforaphane; TCD, transcranial doppler; WFNS, World Federation of Neurosurgical Societies.