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

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

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 .

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Drug: glibenclamide

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: qing lin; Phone Number: 13811127173; Email: 13811127173@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Tongren Hospital, Capital Medical University
    • Contact: qing lin
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Tiantan Hospital Affiliated to Capital Medical University
      • Contact: qing lin; Phone Number: 13811127173; Email: 13811127173@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Glibenclamide was given orally or through nasogastric tube, 1.25 mg every 8 hours for 7 days	Drug: glibenclamide; Glibenclamide was given orally or by nasal feeding; Other Names: encephaledema
No Intervention: Control group; No glibenclamide treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum NSE and S100 β level	change of the serum NSE and S100 β level concentrations	at 1st, 3rd,7th days after recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glasgow coma scale(GOS) score	Glasgow coma scale(GOS) score	at 30 days
Hospital mortality	Hospital mortality	at 30 days
The degree of brain edema	measured by CT	at 3rd,7th days after recruitment
The degree of midline displacement of brain CT	The degree of midline displacement of brain CT	at 3rd,7th days after recruitment
Intracranial pressure	if have	up to 7 days

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Beijing Tongren Hospital
• Investigators: Study Chair: guangzhi shi, doctor, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Hypoglycemic Agents; Physiological Effects of Drugs; Glyburide
• Other Study ID Numbers: glibenclamide study group1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No