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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT05327933
Eligibility Criteria:
Inclusion Criteria:
1. Patients who have undergone surgery by means of one or more burr hole trepanations during the first manifestation of a cSDH (unihemispherical or bihemispherical) detected by computed tomography or magnetic resonance tomography
2. Age ≥18 years
3. Sufficient compliance and ability to consent
4. Patient's informed consent for surgical as well as endovascular interventional procedure and participation in the study
Exclusion Criteria:
1. Conservatively treated cSDH
2. Radiological evidence of an acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma or epidural hematoma
3. Surgical technique: craniotomy, craniectomy, bilateral burr hole trepanation
4. Angiography cannot be performed within 72 hours after surgery
5. Age \<18 years
6. Supervisory relationship
7. Pregnancy
8. Lack of informed consent
9. Lack of compliance
10. Homozygous factor XIII deficiency with residual activity \<10%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05327933
Study Brief:
Protocol Section:
NCT05327933