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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT04229966
Eligibility Criteria:
Inclusion Criteria:
1. Clear medical history of traumatic brain injury;
2. within 12 hours after injury;
3. Supratentorial unilateral acute epidural hematoma on first head CT scan examination;
4. The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with surgical treatment;
5. With informed consent to surgery and trial participation.
Exclusion Criteria:
1. Previous intracranial surgery prior to trauma;
2. Patients with a score of 3 on the GCS, with bilateral fixed and dilated pupils, bleeding diathesis or defective coagulation, or an injury that was deemed to be unsurvivable;
3. CT demonstrates associated other intracranial hematomas e.g. subdural, intracerebral hemorrhage, or large size infarction, which are the main causes of operation;
4. Patients who had injury of the oculomotor nerve;
5. Severe pre-existing disability or severe co-morbidity which would lead to a poor outcome even if the patient is supposed to a good recovery from the TBI;
6. Pregnant female.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04229966
Study Brief:
Protocol Section:
NCT04229966