Status:
COMPLETED
Space Flap for Cerebral Protection Following Decompressive Hemicraniectomy for Stroke
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Infarction
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
In this study the investigators want to investigate to what extent the application of an artificial bone flape (space flap) influences the success of a decompressive craniectomy. In all participants,...
Detailed Description
The destruction of local brain parenchyma after cerebral infarction leads to local swelling within a few days. In the beginning the ischemic brain expand at the expense of the CSF and venous spaces. H...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years
- Decompressive hemi-craniectomy planed for\*:
- Impairment of consciousness or progressive reduction of consciousness and
- Mass effect on brain imaging (oedema exceeding 50% of the MCA territory and midline shift), and
- Exclusion of other causes of impaired consciousness (e.g. hypoperfusion, hypotension, cerebral reinfarction, epileptic seizures
- Informed consent from relatives
Exclusion
- Bilateral, nonreactive, not drug-induced pupillary dilation, associated with coma\*
- Simultaneous presence of all four of the following unfavorable prognostic factors: \*
- Age 50 years
- Involvement of additional vascular territories
- Unilateral pupillary dilation
- GCS\<8
- Severe comorbidity (severe heart failure or myocardial infarction, incurable neoplasia, etc. \*
- Refusal by the patient of this treatment, as known from current interaction with the patient, from existing written documents or related by the patient's proxies. \*
- Known pulmonary or cranial infection
- Any coagulopathy
- Rapid neurological decline prohibiting the extra time needed for space flab production (10min)
- Pregnancy
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04865757
Start Date
July 1 2012
End Date
September 1 2020
Last Update
April 29 2021
Active Locations (1)
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1
Dep. of Neurosurgery, Bern University Hospital
Bern, Switzerland, 3010