traumatic brain injury
Conditions
Interventions
experimental group:siverilostat sodium was injectted in vein
control group:the placebo was injectted in vein
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) between 18 and 75 years old, and the gender is not limited; (2) Imaging examination suggests some supratentorial brain injuries, including cerebral contusion, intracerebral hematoma, subdural hematoma and epidural hematoma; (3) Meet the new global definition of ARDS; (4) GCS <= 12 points; (5) 24h of disease onset; (6) Receiving the test medicine for at least 5 days; (7) The subjects or their family members had a full understanding of the purpose and significance of the trial, volunteered to participate in the clinical trial, and signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) pregnant or lactating women; (2) Expected survival time<48h; (3) Cerebral artery CTA suggests intracranial aneurysm; (4) Combined with chronic respiratory diseases (including but not limited to chronic obstructive pulmonary disease, chronic emphysema, etc.) (5) Patients with blood coagulation dysfunction and intracranial tumors; (6) other end-stage diseases; (7) Subjects undergoing CRRT; (8) Those known to be allergic to civerlastat sodium or excipients and other substances involved in the examination; (9) Combination with other drugs with effects on neutrophil elastase (ulinastatin, hembijing, etc.); (10) Not appropriate according to the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvement rate of the oxygenation index; | — |
Secondary
| Measure | Time frame |
|---|---|
| the rate of tracheostomy;mortality of 30 days;days in ICU;the rate of intracranial infeion; | — |
Countries
China
Contacts
Public ContactXiaofeng Yang
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed