severe craniocerebral injury
Conditions
Interventions
experimental group:Standard treatment + oral glyburide
control group:Standard treatment + oral placebo
Sponsors
Department of Neurosurgery, Nanfang Hospital, Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Ages 18-75 years, male or female; 2) A clear history of closed head trauma; 3) Within 6 hours after the injury; 4) GCS 4-8, GCS score assessed after admission without sedative or anesthetic use; 5) The first head CT plain scan showed cerebral contusion; 6) Intracranial pressure probes were implanted in the operating room immediately after admission and the initial ICP was >= 25mmHg. 7) Patients with oral or gastric tube injection of drugs for drug management research; 8) The patient/family member should be informed and sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: Those who meet the inclusion criteria but meet one of the following conditions will be excluded: 1) Large fixation with dilated pupil and no spontaneous breathing; 2) Severe multiple injuries, or the main injury site is not in the brain; 3) Previous physical or mental disorders that may affect the efficacy evaluation of this study; 4) Patients with severe diseases of heart and lung, liver and kidney, endocrine and hematopoietic systems; 5) Uncertain time of craniocerebral injury; 6) Women of intended pregnancy or childbearing age who have positive pregnancy test and lactating mothers; 7) Those who have participated in other clinical trials in recent 3 months; 8) Systolic blood pressure 250mg/dL; 13) has been hospitalized in the past 3 years for brain trauma, mental illness or neurologically related illness; 14) Use of other sulfonylureas in the last 30 days; 15) Allergic to sulfonylureas; 16) Confirmed g-6-PD enzyme deficiency; 17) Patients whom the investigator considers inappropriate to participate in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GOSE scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| Invasive intracranial pressure;The difference of CT brain edema of head on day 1, day 3, day 7, month 1 or at discharge, and 6 months after injury;All - cause mortality and length of hospital stay within 6 months;Rate of adverse events; | — |
Countries
China
Contacts
Public ContactBinghui Qiu
Department of Neurosurgery, Nanfang Hospital, Southern Medical University
Outcome results
None listed