Rationale and aim
Acute non-traumatic spontaneous intracerebral hemorrhage (ICH) accounts for 16 to 19% of all strokes in Western Europe and contributes profoundly to mortality and disability. Thirty-day case fatality is 40% and of those surviving, only few gain independence. Except for stroke unit care and possibly early blood pressure lowering, there is currently no treatment of proven benefit. Surgical treatment, craniotomy, or minimally invasive surgery with the administration of alteplase, has so far not been proven effective. In the largest trials STICH I and II, and MISTIE III, the median time to treatment was more than 24 hours, which may be an important explanation for the lack of a treatment effect. A recent meta-analysis of randomized controlled trials showed that surgical treatment may be beneficial, in particular with minimally invasive procedures and when performed early.
In the Dutch ICH Surgery pilot study (NCT03608423), we recently showed that early minimally invasive endoscopy-guided surgical treatment performed within 8 hours of symptom onset in patients with supratentorial ICH is safe and technically effective. We hypothesize that early minimally invasive endoscopy-guided surgery improves the outcome in patients with supratentorial spontaneous ICH.
The aim of DIST is to assess whether minimally invasive endoscopy-guided surgery within 8 hours of symptom onset in addition to standard medical management, improves functional outcome after spontaneous supratentorial ICH when compared to standard medical management alone.