Last updated on June 2020

Decompressive Hemicraniectomy in Intracerebral Hemorrhage

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cerebral Hemorrhage
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Written informed consent of the patient or of patient's next of kin plus consent of an independent physician if patient is unable to consent before randomization
  • Acute stroke syndrome due to a spontaneous ICH, defined as the sudden occurrence of bleeding into the parenchyma of the basal ganglia and/or thalamus that may extend into the ventricles and into the cerebral lobes, and into the subarachnoid space, confirmed by clinical history and imaging
  • Age: 18 to 75 years
  • Glasgow coma scale (GCS) <14 and >7
  • Neurological deficit with a NIHSS score of 10 and 30
  • Able to be randomly assigned to surgical treatment within 66 hours after ictus
  • Surgery performed not later than 6 hours after randomization
  • Volume of hematoma 30 ml and 100 ml
  • Stable clot volume
  • International normalized ratio (INR) <1.5, thrombocytes >100 T/ml

Exclusion Criteria

  • ICH due to known or suspected structural abnormality in the brain (e.g., intracranial aneurysm, brain arteriovenous malformation, brain tumor) or brain trauma, or previous stroke thrombolysis
  • Cerebellar or brainstem hemorrhage
  • Exclusive lobar hemorrhage
  • Known advanced dementia or significant pre-stroke disability
  • Concomitant medical illness that would interfere with outcome assessment and follow-up
  • Randomization not possible within 66 hours after ictus
  • Pregnancy
  • Prior major brain surgery within <6 month or prior DC
  • Foreseeable difficulties in follow-up due to geographic reasons
  • Known definite contraindication for a surgical procedure
  • A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
  • Previous participation in this trial or in another ongoing investigational trial
  • Prior symptomatic ICH
  • ICH secondary to thrombolysis
  • Bilateral areactive pupils

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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