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

Traumatic Brain Injury Clinical Trial

Official title:

Evaluation of Safety and Efficacy of Glibenclamide in the Treatment of Severe Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05148403
• Other study ID #: glibenclamide study group1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 22, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: November 2021
• Source: Beijing Tiantan Hospital
• Contact: qing lin
• Phone: 13811127173
• Email: 13811127173[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Description:

Traumatic brain injury has high morbidity,disability and mortality ; worldwide, more than 50 million new cases , mainly low and middle-income countries.The annual incidence of craniocerebral trauma in China is (55 - 64) / 100000 , with 770 - 890 thousand new cases,causing nearly 100000 deaths and hundreds of thousands of disabilities , which is a serious public safety problem .Injury mechanisms after traumatic brain injury include primary and secondary brain injury and have a lack of effective treatment .Brain edema is one of the main mechanisms of secondary brain injury and one factor in the prognosis of traumatic brain injury .In recent years , the Sur1-Trpm4 channel was found to play an important role in the onset of brain edema , with increased expression in traumatic brain injury , ischemic stroke , and ischemic and hypoxic encephalopathy , and the specific inhibitor glibenclamide can reduce brain edema .A clinical study of glibenclamide in the treatment of brain edema after traumatic brain injury 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Drug:
• glibenclamide
Glibenclamide was given orally or by nasal feeding

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital Affiliated to Capital Medical University	Beijing	Beijing
China	Beijing Tongren Hospital, Capital Medical University	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum NSE and S100 ß level	change of the serum NSE and S100 ß level concentrations	at 1st, 3rd,7th days after recruitment
Secondary	Glasgow coma scale(GOS) score	Glasgow coma scale(GOS) score	at 30 days
Secondary	Hospital mortality	Hospital mortality	at 30 days
Secondary	The degree of brain edema	measured by CT	at 3rd,7th days after recruitment
Secondary	The degree of midline displacement of brain CT	The degree of midline displacement of brain CT	at 3rd,7th days after recruitment
Secondary	Intracranial pressure	if have	up to 7 days