Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02258919 : Decompressive Hemicraniectomy in Intracerebral Hemorrhage
PhaseN/A
AgesMin: 18 Years Max: 75 Years
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02258919      |      Link to official Clinicaltrials.gov listing
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