Space Flap for Cerebral Protection Following Decompressive Hemicraniectomy for Stroke (NCT04865757) | Clinical Trial Compass
CompletedNot Applicable
Space Flap for Cerebral Protection Following Decompressive Hemicraniectomy for Stroke
Switzerland10 participantsStarted 2012-07
Plain-language 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, a space flap is placed immediately after removal of the skull cap. In a second operation, after 1-3 months, an operation is performed, in which the stored own skull bone is re-inserted. The artificial bone cover is removed at this point.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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