Evaluation of Safety and Efficacy of Glibenclamide in the Treatment of Severe Traumatic Brain Injury
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Serum NSE and S100 β level
研究概览
简要总结
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 .
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label, result blind method
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •There was a history of participating in other drug trials within 30 days before brain injury;
- •There was a history of G6PD deficiency;
- •There were clinical conditions that other researchers did not consider to meet the inclusion criteria.
研究组 & 干预措施
Experimental group
Glibenclamide was given orally or through nasogastric tube, 1.25 mg every 8 hours for 7 days
干预措施: glibenclamide (Drug)
结局指标
主要结局
Serum NSE and S100 β level
时间窗: at 1st, 3rd,7th days after recruitment
change of the serum NSE and S100 β level concentrations
次要结局
- Glasgow coma scale(GOS) score(at 30 days)
- Hospital mortality(at 30 days)
- The degree of brain edema(at 3rd,7th days after recruitment)
- The degree of midline displacement of brain CT(at 3rd,7th days after recruitment)
- Intracranial pressure(up to 7 days)
研究者
Guangzhi Shi
chief physician
Beijing Tiantan Hospital