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 @ 3:05 AM
Ignite Modification Date:
2025-12-25 @ 3:05 AM
NCT ID:
NCT06466733
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 21
* Speak and understand Spanish or English
* Resident of Puerto Rico
* Glasgow coma scale ≥ 14/15
* Presence of cSDH on non-contrast computed tomography (NCCT) or magnetic resonance imaging (MRI)
* Neurological indication for treatment of cSDH (Markwalder scale ≤ 2)
* No previous surgical or endovascular treatment for symptomatic cSDH
* Signed informed consent for participation in the study by the patient or legally authorized representative
Exclusion Criteria:
* Acute subdural hematoma
* Focal, non-hemispheric localization of cSDH
* Evidence of other lesions associated with cSDH, such as neoplasms, vascular lesions, or additional epidural, subarachnoid, or parenchymal hemorrhage on non-contrast computed tomography or magnetic resonance imaging
* Imaging evidence of skull fracture over the subdural hematoma
* Presence of any cerebrospinal fluid (CSF) shunt
* Imaging evidence of midline shift ≥ 10 mm
* Imaging evidence of basal cistern effacement
* Imaging evidence of dilatation of lateral ventricles
* Imaging evidence of uncal herniation
* Modified Rankin scale ≥ 3 before developing symptoms associated with cSDH
* Contraindications for angiography (i.e., complex anatomy or kidney failure)
* Comorbidity making follow-up impossible
* Pregnancy
* Vulnerable patients, including homeless patients, incarcerated patients, and mentally ill patients without appropriate medical decision-making proxies that the physician believes are incapable of appropriately assessing the risks of the procedure
* Absence of medical insurance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT06466733
Study Brief:
Protocol Section:
NCT06466733