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:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT07285733
Eligibility Criteria:
This study is based on the 50 patients recruited for the original study.
For TBI:
Inclusion Criteria:
* male or female patients aged 18 to 70 years, inclusive
* sustained head injury within the previous 24 hours
* TBI diagnosed by history, clinical examination with a GCS of 12 or less
* evidence of TBI confirmed by abnormalities on CT scan
* clinical indication to monitor ICP
* informed consent is obtained from the patient or from a legally acceptable representative
Exclusion Criteria:
* life expectancy of less than 24 hours as determined by the investigator
* any spinal cord injury
* coma suspected to be primarily due to causes other than head injury, such as drug or alcohol overdose
* clinically significant or active gastro-intestinal, renal, hepatic, endocrine or CNS disease or chronic condition (e.g.psychiatric disorder) that can be ascertained at the time of admission and could affect functional outcome
* respiratory/hemodynamic instability, refractory to treatment and precluding transport for neuroimaging studies
* pregnancy
* special exclusion criteria for MRI, such as non-removable metals, artificial joints, electronic devices (pacemaker, pumps etc.)
* informed consent is obtained from a legally acceptable representative, prior to any study related activity
For aneurysmal subarachnoid hemorrhage:
Inclusion Criteria:
* male or female patients aged 18 to 70 years, inclusive
* ruptured aneurysm, demonstrated by CT angiography or DSA
* onset of SAH clinical symptoms within the preceding 72 hours
* World Federation of Neurosurgery (WFNS) grade III-IV and grade V patients, who improve within 24 hours after ventriculostomy
* indication for ICP monitoring or CSF drainage
* informed consent is obtained from the patient or a legally acceptable representative
Exclusion Criteria:
* non-aneurysmal subarachnoid hemorrhage
* admission in a clinical state with extremely poor prognosis (e.g. wide, non-reactive pupils for more than 1 hour)
* significant coagulation disturbances (thrombocytes \< 80 per mL, partial thromboplastin time \> 45 sec, INR \> 1.5)
* cytostatic therapy in patients with malignant disease
* pregnancy
* special exclusion criteria for MRI, such as non-removable metals, artificial joints, electronic devices (pacemaker, pumps etc.)
* respiratory and/or hemodynamic instability precluding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07285733
Study Brief:
Protocol Section:
NCT07285733