Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT04865757
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04865757
Study Brief:
Protocol Section:
NCT04865757