To Evaluate the Effect of Glibenclamide in Reducing Brain Edema of TBI

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Brain edema is one of the main mechanisms of secondary brain injury and one factor in the prognosis of traumatic brain injury . The clinical study of glibenclamide in the treatment of brain edema after traumatic brain injury is designed to evaluate whether glibenclamide treatment can improve the blood NSE and S100β levels of severe traumatic brain injury , so order to explore the efficacy and adverse effects of this drug in the treatment of traumatic brain injury .

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Collaborator: Beijing Tongren Hospital
• Treatments: Glyburide

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.