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

Primary Purpose

Traumatic Brain Injury

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
glibenclamide
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tiantan Hospital Affiliated to Capital Medical UniversityRecruiting
  • Beijing Tongren Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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

No glibenclamide treatment

Outcomes

Primary Outcome Measures

Serum NSE and S100 β level
change of the serum NSE and S100 β level concentrations

Secondary Outcome Measures

Glasgow coma scale(GOS) score
Glasgow coma scale(GOS) score
Hospital mortality
Hospital mortality
The degree of brain edema
measured by CT
The degree of midline displacement of brain CT
The degree of midline displacement of brain CT
Intracranial pressure
if have

Full Information

First Posted
October 19, 2021
Last Updated
November 24, 2021
Sponsor
Beijing Tiantan Hospital
Collaborators
Beijing Tongren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05148403
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Beijing Tongren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
Open label, result blind method
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Glibenclamide was given orally or through nasogastric tube, 1.25 mg every 8 hours for 7 days
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No glibenclamide treatment
Intervention Type
Drug
Intervention Name(s)
glibenclamide
Other Intervention Name(s)
encephaledema
Intervention Description
Glibenclamide was given orally or by nasal feeding
Primary Outcome Measure Information:
Title
Serum NSE and S100 β level
Description
change of the serum NSE and S100 β level concentrations
Time Frame
at 1st, 3rd,7th days after recruitment
Secondary Outcome Measure Information:
Title
Glasgow coma scale(GOS) score
Description
Glasgow coma scale(GOS) score
Time Frame
at 30 days
Title
Hospital mortality
Description
Hospital mortality
Time Frame
at 30 days
Title
The degree of brain edema
Description
measured by CT
Time Frame
at 3rd,7th days after recruitment
Title
The degree of midline displacement of brain CT
Description
The degree of midline displacement of brain CT
Time Frame
at 3rd,7th days after recruitment
Title
Intracranial pressure
Description
if have
Time Frame
up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Closed craniocerebral trauma; The injury time on admission was less than 10 hours; The GCS score was less than 9, and the GCS score was evaluated without sedation or using muscle relaxants; They were 18-75 years old; Authorized close relatives to sign informed consent. Exclusion Criteria: The damage time is uncertain; Penetrating brain injury; With spinal cord injury; Severe and fatal injuries associated with other parts of the body; Pregnant women or pregnancy test positive; Lactating women had lactation needs during the study period; blood suger is lower than 2.8 mmol / L; Renal insufficiency, history of dialysis treatment, or serum creatinine more than 2.5 mg / dl; The total bilirubin was more than 1.5 times of the upper limit; INR was greater than 1.4; Systolic blood pressure was less than 90 and had no response to fluid resuscitation; Allergic to sulfonylureas; There was a history of admission for brain injury, mental or neurological diseases within 3 years before brain injury; The drug use was restricted due to emergency operation within 8 hours after brain injury; There was a history of taking antiplatelet drugs, oral anticoagulants or heparin or low molecular weight heparin 72 hours before brain injury; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
qing lin
Phone
13811127173
Email
13811127173@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
guangzhi shi, doctor
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Tiantan Hospital Affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qing lin
Phone
13811127173
Email
13811127173@163.com
Facility Name
Beijing Tongren Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qing lin

12. IPD Sharing Statement

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

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