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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT06391203
Eligibility Criteria:
Inclusion Criteria:
1. Unilateral DC surgery was performed on TBI patients after injury;
2. Subdural effusion occurred for the first time and occurred within 30 days after DC surgery;
3. Unilateral effusion accumulation (can appear on the same or opposite side of the bone flap);
4. The subdural effusion cannot be absorbed or has no decreasing trend with conservative treatment and consistent with the indications for surgical treatment;
5. Sign the study informed consent;
Exclusion Criteria:
1. History of craniocerebral disease or craniocerebral surgery;
2. Patients with intracranial infection (cerebrospinal fluid test results must be confirmed by lumbar puncture before inclusion);
3. Combined with ventricular hydrocephalus;
4. Other factors lead to poor prognosis or affect the treatment plan of the patient, even if the effusion can be recovered well, but severe pre-existing disability or severe co-morbidity such as serious heart disease leads to poor prognosis or even death;
5. Pregnant female.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06391203
Study Brief:
Protocol Section:
NCT06391203