Rationale and aim
Intracerebral hemorrhage (ICH) accounts for 15-20% of all strokes in Western Europe. On a global scale, the burden of ICH in terms of ‘lost-productive-life-years’ is large. Thirty-day case fatality is 40% and of those surviving, only few gain independence. Important predictors of poor outcome are increasing age, decreasing Glasgow Coma Scale score, increasing ICH volume, presence of intraventricular hemorrhage, and deep or infratentorial location. In around 30% of patients, hematoma volume increases with at least 30% in the first 24 hours, mostly within the first couple of hours. In addition, secondary injury, due to development of edema and an inflammatory response, contribute to disability and death. In the Netherlands, 50% of ICH patients present within three hours of symptom onset. Except for stroke unit care and early blood pressure lowering there is currently no treatment of proven benefit.
Surgical treatment, mostly comprising craniotomy, has so far not been proven effective. In the largest trials STICH I, STICH II and MISTIE III, the median time to treatment was more than 24 hours, which may be an important explanation for the lack of treatment effect.
Recent systematic reviews of minimally-invasive intervention trials suggested overwhelming efficacy, but the largest study that was incorporated in the reviews did not have blinded outcome assessment and excluded patients who had rebleeds after randomization.
Several studies have assessed minimally-invasive techniques to evacuate the hematoma. These include stereotactic aspiration, mostly with thrombolytic agents and endoscopic techniques. Several small series and a few small trials have been published, indicating that both techniques can be applied safely but effectiveness has not yet been proven. The MISTIE II trial demonstrated a significant reduction of minimally invasive surgery plus rt-PA in perihematomal edema in the hematoma evacuation group compared to medically treated patients, with a trend toward improved outcomes. Recently, the MISTIE III trial showed that minimally invasive haematoma aspiration with local application of alteplase up to 72 hours after surgery did not seem to be superior to standard medical care. However, surgery in this trial was also performed late, on average 58 hours after symptom onset.
In recent reports, the treatment of patients with a combined approach of endoscopy and a vibrating aspiration device that obviates the need for thrombolytics, worked well and faster than lytic-based aspiration, with few complications. Recent systematic reviews of minimally-invasive intervention trials suggested overwhelming efficacy, but the largest study that was incorporated in the reviews did not have blinded outcome assessment and excluded patients who had rebleeds after randomization.
We hypothesize that minimally-invasive endoscopy-guided microsurgical treatment when started early, may lead to reduced mortality and better functional outcome after acute ICH.
In preparation of a randomized phase III trial to compare early minimally-invasive endoscopy-guided surgery for the treatment of ICH as compared to the standard treatment we aim to assess safety, feasibility and technical effectiveness of minimally-invasive endoscopy-guided surgery within 8 hours of onset for treatment of supratentorial ICH and to estimate the potential effect of minimally-invasive endoscopy-guided surgery on functional outcome in patients with supratentorial ICH.