Traumatic Brain InjuryPhase 1/2NCT05148403
To Evaluate the Effect of Glibenclamide in Reducing Brain Edema of TBI
A Phase 1/2 study testing glibenclamide in people with Traumatic Brain Injury, run by Beijing Tiantan Hospital at 2 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- glibenclamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesChina
- Study dates
- 22 Oct 2021to 1 Oct 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100050
qing lin, 13811127173, 13811127173@163.com
- Recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing
qing lin
About this study
Official title: 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 .
Read the 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 .
- Conditions
- Traumatic Brain Injury
- Being tested
- glibenclamide
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glibenclamideDrug
Also called encephaledema
Glibenclamide was given orally or by nasal feeding
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Glibenclamide was given orally or through nasogastric tube, 1.25 mg every 8 hours for 7 days Receives: Drug: glibenclamide |
| Control group | No intervention | No glibenclamide treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum NSE and S100 β level
change of the serum NSE and S100 β level concentrations
Measured: at 1st, 3rd,7th days after recruitment
Secondary outcomes (5)
Glasgow coma scale(GOS) score
Glasgow coma scale(GOS) score
Measured: at 30 days
Hospital mortality
Hospital mortality
Measured: at 30 days
The degree of brain edema
measured by CT
Measured: at 3rd,7th days after recruitment
The degree of midline displacement of brain CT
The degree of midline displacement of brain CT
Measured: at 3rd,7th days after recruitment
Intracranial pressure
if have
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start22 Oct 2021
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tongren Hospital
- Responsible party
- Principal investigator, Guangzhi Shi, Beijing Tiantan Hospital
- Investigators
- guangzhi shi, doctor, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148403
- Sponsor's protocol ID
- glibenclamide study group1
- Status last verified
- Nov 2021
- First submitted
- 19 Oct 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Glibenclamide in the Treatment of Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05148403
- Acronym / sponsor ID
- glibenclamide study group1
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Tongren Hospital
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: glibenclamideGlibenclamide was given orally or through nasogastric tube, 1.25 mg every 8 hours for 7 days |
| Control group | No intervention | –No glibenclamide treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glibenclamideAlso: encephaledemaGlibenclamide was given orally or by nasal feeding | Drug | Experimental group |
Primary outcome
Serum NSE and S100 β level
Time frame: at 1st, 3rd,7th days after recruitment
change of the serum NSE and S100 β level concentrations
5 secondary outcomes
Glasgow coma scale(GOS) score
Time frame: at 30 days
Hospital mortality
Time frame: at 30 days
The degree of brain edema
Time frame: at 3rd,7th days after recruitment
The degree of midline displacement of brain CT
Time frame: at 3rd,7th days after recruitment
Intracranial pressure
Time frame: up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
guangzhi shi, doctor study chair
Beijing Tiantan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing glibenclamide in people with Traumatic Brain Injury, run by Beijing Tiantan Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact qing lin (13811127173, 13811127173@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum NSE and S100 β level (time frame: at 1st, 3rd,7th days after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.