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 @ 9:55 PM
Ignite Modification Date:
2025-12-24 @ 9:55 PM
NCT ID:
NCT02716532
Eligibility Criteria:
Inclusion Criteria:
* Comatose patients (defined by an initial Glasgow Coma Scale (GCS) \< 9) following sTBI or aSAH.
* Female or male, aged \>18.
* Abnormal head CT-Scan (contusions, hematoma).
* Intracranial monitoring with CMD, \[PbtO2\] and \[ICP\] probes as part of standard of care.
* Written informed consent from an independent physician (not associated to the research project) who provides medical follow-up and defends patient's interests.
* Written informed consent from patient relative/legal representative confirming the presumed patient willingness to participate in the study
Exclusion Criteria:
* Signs of brain death or expected brain death within 48h.
* Pregnancy.
* Hemodynamic instability (circulatory shock, requiring vasopressors).
* Renal or liver insufficiency .
* Chronic intestinal disease.
* Patients requiring parenteral nutrition .
* Currently participating or having participated in another clinical trial during the month preceding the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02716532
Study Brief:
Protocol Section:
NCT02716532