craniocerebral injury
Conditions
Interventions
Experimental group:compound procine cerebroside and ganglioside injection
Control group:Piracetam Injection
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Aged from 18 to 75 years, regardless of gender; 2) Craniocerebral injury meets all the following conditions: There are definite head injuries in this diagnosis, including closed craniocerebral injury, or craniocerebral injury with cerebrospinal fluid otorrhea and/or rhinorrhea and/or intracranial pneumatosis, MRI or CT confirmed intracranial hemorrhage above tentorium cerebelli (including cerebral contusion and laceration, subarachnoid hemorrhage, epidural hematoma, subdural hematoma, intracerebral hematoma, etc.) or intracranial pneumatosis or skull fracture; 3) Craniocerebral injury was classified as mild and moderate (GCS score 9 to 15); 4) Conservative treatment, non craniotomy treatment (could have invasive intracranial pressure monitoring of brain parenchyma); 5) The mini mental state examination (MMSE) score was lower than normal in patients with stable vital signs within 72 hours after craniocerebral injury, and the diagnostic cut-off value was determined according to different educational levels: illiterate (uneducated) <=19 points, primary school level <=22 points, junior high school level and above <=26 points; 6) They agreed to participate in the clinical trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1) Known or suspected to be allergic to the test drug and its ingredients; 2) Patients with Guillain Barre syndrome, extrapyramidal diseases and Huntington's chorea; 3) Patients with a history of severe craniocerebral trauma, structural brain lesions and cognitive or intellectual impairment in the past; 4) Patients with speech/hearing impairment who can not cooperate to complete cognitive function assessment; 5) Secondary brain injury occurred after this craniocerebral injury; 6) Patients who need craniotomy or ventricular drainage; 7) Patients with other severe large organ injury or serious complications that may affect the life of the subjects; 8) Active epilepsy patients with seizures within one year; 9) Patients with severe heart disease, lung disease, liver and kidney disease (ALT or AST >=2.0 ULN, SCR > ULN), blood and hematopoietic system disease, gastrointestinal disease, malignant tumor or other serious or progressive diseases, the researcher assessed as severe abnormal coagulation function; 10) Those who have neurological or mental disorders and are unable to cooperate or are unwilling to cooperate; 11) Suspected or confirmed history of alcohol and drug abuse, or tendency of drug dependence; 12) Pregnant and lactating women or those who have fertility planning recently; 13) Participants in other clinical trials within three months; 14) The researchers did not consider the patient appropriate to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MoCA; | — |
Secondary
| Measure | Time frame |
|---|---|
| MMSE;GOS-E;GCS;Barthel Index;NHISS; | — |
Countries
China
Contacts
Public ContactYue Shuyuan
Tianjin Medical University General Hospital
Outcome results
None listed