Dutch Intracerebral Hemorrhage Surgery Trial
Dutch Intracerebral Hemorrhage Surgery Trial
Background:

 Intracerebral hemorrhage (ICH) accounts for 15-20% 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 early blood
 pressure lowering there is currently no treatment of proven benefit. 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 addition,
 secondary injury due to development of edema and inflammatory response, contribute to
 disability and death. Surgical treatment, mostly comprising craniotomy, has so far not been
 proven effective. In the largest trials STICH and STICH II, the median time to treatment was
 more than 24 hours, which may be an important explanation for the lack of treatment effect.

 The investigators hypothesize that early, minimally-invasive, endoscopy-guided surgery
 improves outcome in patients with spontaneous supratentorial ICH.

 Objective: to study safety, feasibility and technical effectiveness of minimally-invasive
 endoscopy guided surgery for treatment of spontaneous supratentorial ICH and to estimate the
 potential effect on outcome.

 Study design: a multicenter, prospective intervention study (phase II) with a telephonic
 follow up interview at 90 and 180 days.The pilot study serves as a prelude to a randomized
 phase III trial in which the investigators aim to assess whether this intervention improves
 functional outcome at 90 and 180 days.

 Study population: patients with spontaneous supratentorial ICH of 18 years and older. Forty
 patients in three participating centers (Radboudumc, Erasmus MC and AMC) will undergo
 minimally-invasive endoscopy-guided surgery. Three-hundred-and-sixty patients undergoing
 standard medical treatment in one of 7 other participating centers, will be included as a
 control group.

 Intervention: minimally-invasive endoscopy-guided surgery within 8 hours of symptom onset, in
 addition to standard medical management.

 Primary study outcomes: safety (death within 24 hours, 7-day procedure related complications,
 7-day mortality, 30-day mortality) and technical effectiveness (proportional volume
 reduction, proportion of participants with volume reduction > 60 and >80%, and proportion
 with remaining clot volume <15mL).

 Secondary outcomes: modified Rankin Scale score at 90 and 180 days after ICH (functional
 outcome).
The full protocol is available at
 https://dutch-ich.nl/trial-protocol-and-trial-documents.html
Inclusion Criteria:

 1. Age ≥ 18

 2. NIHSS ≥ 2

 3. Supratentorial ICH confirmed by CT, without a CT-angiography confirmed causative
 vascular lesion (e.g. aneurysma, arteriovenous malformation [AVM], dural arteriovenous
 fistula [DAVF], cerebral venous sinus thrombosis [CVST]).

 4. Minimal lesion size 10 mL

 5. Intervention can be started within 8 hours from symptoms onset; or for controls
 presentation within 8 hours of symptom onset.

 6. Patient's or legal representative's written informed consent

 Exclusion Criteria:

 1. Pre-stroke disability, which interferes with the assessment of functional outcome at
 90 days, i.e. mRS > 2

 2. Causative vascular lesion (e.g. aneurysm, AVM, DAVF, CVST) on CT-angiography or other
 known underlying cause (e.g. tumor, cavernoma)

 3. Untreated coagulation abnormalities, including INR > 1.3 (point of care measurement
 allowed) and treatment with oral thrombin or factor X antagonists; patients on vitamin
 K antagonist can be included after correction of the INR.

 4. Current known severe infection for which antibiotic treatment at time of ICH symptom
 onset

 5. Patient moribund (e.g. coning, bilateral dilated unresponsive pupils)

 6. Pregnancy (note: most patients will be beyond child bearing age; if not a pregnancy
 test is mandatory).