Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Tongren Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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 .
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 .
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Glibenclamide was given orally or through nasogastric tube, 1.25 mg every 8 hours for 7 days |
|
| Control group | No Intervention | No glibenclamide treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glibenclamide | Drug | Glibenclamide was given orally or by nasal feeding |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Glasgow coma scale(GOS) score | Glasgow coma scale(GOS) score | at 30 days |
| Hospital mortality | Hospital mortality | at 30 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
18. There was a history of G6PD deficiency; 19. There were clinical conditions that other researchers did not consider to meet the inclusion criteria.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| qing lin | Contact | 13811127173 | 13811127173@163.com |
| Name | Affiliation | Role |
|---|---|---|
| guangzhi shi, doctor | Beijing Tiantan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital Affiliated to Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
Not provided
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005905 | Glyburide |
| ID | Term |
|---|---|
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
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.
Not provided
Not provided
Open label, result blind method
Not provided
| 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 |
| Beijing Tongren Hospital, Capital Medical University | Recruiting | Beijing | China |
|
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D013450 |
| Sulfones |
| D013457 | Sulfur Compounds |