Status:
COMPLETED
Decompressive Hemicraniectomy in Intracerebral Hemorrhage
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Cerebral Hemorrhage
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Spontaneous intracerebral hemorrhage (ICH) remains a devastating disease with mortality rates up to 52% at 30 days. It is a major public health problem with an annual incidence of 10-30 per 100'000 po...
Detailed Description
Background Spontaneous intracerebral hemorrhage (ICH) remains a devastating disease with mortality rates up to 52% at 30 days. It is a major public health problem with an annual incidence of 10-30 pe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2024
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT02258919
Start Date
October 1 2014
End Date
May 23 2024
Last Update
November 14 2024
Active Locations (32)
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1
Universitätsklinik für Neurochirurgie, Kepler Universitätsklinikum Linz
Linz, Austria, 4020
2
UZ Leuven
Leuven, Belgium, 3000
3
Department of Neurology, Helsinki University Central Hospital
Helsinki, Finland, 00290
4
Centre Hospitalier Universitaire de Caen
Caen, France, 14033