Clinical trial NCT05148403: To Evaluate the Effect of Glibenclamide in Reducing Brain Edema of TBI
Official title: Evaluation of Safety and Efficacy of Glibenclamide in the Treatment of Severe Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Traumatic Brain Injury
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tongren Hospital
First posted: 2021-12-08
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients in the case group were treated with glibenclamide within 10 hours after onset, orally or through nasogastric tube, 1.25 mg each time, once every 8 hours, for 7 consecutive days. The control group was blank control.
Primary purpose: TREATMENT

Brief 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 .

Detailed 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 .

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.

Primary outcomes:
measure: Serum NSE and S100 β level
timeFrame: at 1st, 3rd,7th days after recruitment
Secondary outcomes:
measure: Glasgow coma scale(GOS) score
timeFrame: at 30 days
measure: Hospital mortality
timeFrame: at 30 days
measure: The degree of brain edema
timeFrame: at 3rd,7th days after recruitment
measure: The degree of midline displacement of brain CT
timeFrame: at 3rd,7th days after recruitment
measure: Intracranial pressure
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
Study officials:
affiliation: Beijing Tiantan Hospital
name: guangzhi shi, doctor
role: STUDY_CHAIR
References: