Diffusion-weighted-imaging (DWI) lesions, consistent with cerebral infarction, occur in ~30% of patients with acute intracerebral hemorrhage (ICH), are associated with increased ICH volume, and have been independently associated with negative long-term outcomes. We aim to better understand the relationships between acute ICH and DWI-lesion development. Specifically, we will perform an imaging sub-study of the ongoing EVACUATE trial to explore the natural history of DWI-lesion development in patients who undergo acute hematoma evacuation versus patients who receive standard of care. We hypothesize that the removal of blood in the early stages of ICH onset could reduce the incidence of subsequent brain infarction.
Patients enrolled into the EVACUATE trial (randomized to either minimally invasive surgery or standard of care within 8 hours of symptom onset) and later-presenting conservatively managed patients otherwise meeting trial eligibility, will undergo an MRI at days 3-7 from symptom onset and will receive clinical follow-up (mRS, NIHSS, MoCA) at 90 days.
Our primary outcome will be the proportion of patients who are DWI-lesion positive at days 3-7. We will recruit 137 patients (1:1.5 ratio [intervention/control]), to identify a clinically meaningful 20% difference in DWI-lesion positivity. Differences in proportions will be adjusted for baseline white matter disease and cerebral microbleeds using Firth logistic regression models.
Funding has been acquired and patient recruitment is due to begin in Q2 2021. The findings of this study may shed further light on ICH pathophysiology and potentially identify new treatment targets for future therapies.
The study described above is an imaging sub-study occuring within the structure of the EVACUATE (NCT04434807) trial.