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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT05148403
Eligibility Criteria:
Inclusion Criteria:
1. Closed craniocerebral trauma;
2. The injury time on admission was less than 10 hours;
3. The GCS score was less than 9, and the GCS score was evaluated without sedation or using muscle relaxants;
4. They were 18-75 years old;
5. Authorized close relatives to sign informed consent.
Exclusion Criteria:
1. The damage time is uncertain;
2. Penetrating brain injury;
3. With spinal cord injury;
4. Severe and fatal injuries associated with other parts of the body;
5. Pregnant women or pregnancy test positive;
6. Lactating women had lactation needs during the study period;
7. blood suger is lower than 2.8 mmol / L;
8. Renal insufficiency, history of dialysis treatment, or serum creatinine more than 2.5 mg / dl;
9. The total bilirubin was more than 1.5 times of the upper limit;
10. INR was greater than 1.4;
11. Systolic blood pressure was less than 90 and had no response to fluid resuscitation;
12. Allergic to sulfonylureas;
13. There was a history of admission for brain injury, mental or neurological diseases within 3 years before brain injury;
14. The drug use was restricted due to emergency operation within 8 hours after brain injury;
15. There was a history of taking antiplatelet drugs, oral anticoagulants or heparin or low molecular weight heparin 72 hours before brain injury;
16. There was a history of taking sulfonylureas within 30 days before brain injury; 17. There was a history of participating in other drug trials within 30 days before brain injury;
18\. There was a history of G6PD deficiency; 19. There were clinical conditions that other researchers did not consider to meet the inclusion criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05148403
Study Brief:
Protocol Section:
NCT05148403