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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT07240467
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years;
* Clinically diagnosed with ischemic cerebral infarction;
* GCS score: 3-12;
* Time from symptom onset to randomization ≤ 24 hours, including wake-up stroke or stroke without a witness; the time of symptom onset is defined as the "last known well time";
* Pre-stroke mRS score of 0-1;
* Head CT excludes intracranial hemorrhage or other non-ischemic pathologies;
* The participant or legally authorized representative is capable of providing informed consent.
Exclusion Criteria:
* Use of in BCS within 24 hours before treatment;
* Known pregnancy or breastfeeding, or positive pregnancy test before randomization;
* Allergy to BCS;
* Impaired consciousness caused by other diseases, such as metabolic disorders (e.g., ketoacidosis), trauma, infectious diseases (e.g., pneumonia), neoplastic diseases (e.g., glioma), or toxic conditions (e.g., organophosphate poisoning);
* Requiring or undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency (glomerular filtration rate \<30 mL/min or serum creatinine \>220 μmol/L);
* Expected survival time less than 6 months (e.g., due to malignancy, severe cardiopulmonary disease, etc.);
* Participation in other interventional clinical studies that may affect outcome assessment;
* Other conditions deemed by the investigator to make the patient unsuitable for participation or pose significant risks (e.g., inability to understand and/or comply with study procedures and/or follow-up due to mental illness, cognitive or emotional disorders).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07240467
Study Brief:
Protocol Section:
NCT07240467