Nedan följer ett studieschema för de olika undersökningarna i Rädda Hjärnblödningen, markerat med en asterix (*) och TICH-3. Som framgår av studieschemat så är undersökningarna för TICH-3 mycket få. För det lokala centret, handlar det om inkluderingen, vården under på sjukhuset samt vid utskrivning. Uppföljningen är sköts central.
Däremot är uppföljningen i Rädda hjärnan lokal, vid 1 år, då den viktiga undersökninge är Montreal Cognitive Assessment (MoCA).
| RÄDDA HJÄRNBLÖDNINGEN | Screening | Baseline | 7 D | Death or Discharge | 180 D | *Year 1-10 |
| CT/MRI | x | |||||
| Clinical Assessment, NIHSS, Glasgow Coma Scale, Blood Pressure | x | x | ||||
| Eligibility screening, consent | x | |||||
| Randomisation, administration of IMP | x | |||||
| Safety outcomes | x | x | x | x | ||
| Modified Rankin Scale | Pre-stroke | x | x | |||
| Quality of life (EQ-5D-5L) | Pre-stroke | x | x | |||
| Cognition (AD-8) | x | x | ||||
| *Resource, medication, return to work | x | x | x | |||
| *SGPALS (Physical Assessment) | x | x | ||||
| *IQCODE (pre-cognition), Radiology | x | x | ||||
| *Depression (HADS) | x | |||||
| *Cognition face-to-face (MoCA) | x | |||||
| * Fatigue (MFI-20) | x | |||||
| *Blood sample** (baseline and year 1) | x | x |
Table. Data collection in Rädda hjärnblödningen. CT/MRI=Computed Tomography or Magnetic Resonance Imaging (of the brain); IMP=Investigator Medical Product; NIHSS=National Institutes of Health Stroke Scale; AD-8=Washington University Dementia Screening Tool; SGPALS=Saltin-Grimby Physical Activity Level Scale; IQCODE=The Informant Questionnaire on Cognitive Decline in the Elderly; HADS=Hospital Anxiety and Depression Scale; MoCA=Montreal Cognitive Assessment. MFI-20=Multidimensional Fatigue Inventory. Follow-up yearly in 10 years, both for patient and relative. Safety outcomes: death, pulmonary embolism, ischemic events, epileptic seizures.
* denotes what is unique for Rädda hjärnblödningen compared with the mother study TICH-3.
** Venous blood samples to assess biomarkers of cerebral injury, coagulation, cardiovascular risk, and other circulating biomarkers associated with stroke and stroke risk (including, but not limited to, NFL, GFAP, Tau, UCHL1, MMP-9, Fibrinogen, D-dimer, ferritin, PT, aPTT, platelet count and NT-proBNP) will be collected at baseline and at 1 year follow up, and stored up to 15 years after completion of the study.