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

NCT ID: NCT05148403

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-22

Study Completion Date

2022-10-01

Brief Summary

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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

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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 .

Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label, result blind method

Study Groups

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Experimental group

Glibenclamide was given orally or through nasogastric tube, 1.25 mg every 8 hours for 7 days

Group Type EXPERIMENTAL

glibenclamide

Intervention Type DRUG

Glibenclamide was given orally or by nasal feeding

Control group

No glibenclamide treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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glibenclamide

Glibenclamide was given orally or by nasal feeding

Intervention Type DRUG

Other Intervention Names

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encephaledema

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guangzhi Shi

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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guangzhi shi, doctor

Role: STUDY_CHAIR

Beijing Tiantan Hospital

Locations

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Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Tongren Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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qing lin

Role: CONTACT

Phone: 13811127173

Email: [email protected]

Facility Contacts

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qing lin

Role: primary

qing lin

Role: primary

Other Identifiers

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glibenclamide study group1

Identifier Type: -

Identifier Source: org_study_id