spinal cord injury
Conditions
Interventions
Intervention group:Given methylprednisolone (80mg, bid, 1 week before admission), cobamamide (500ug, qd, 2 weeks after admission) and lansoprazole (100mg within 24 hours after admission, bid, po, then
control group:Given methylprednisolone (80mg, bid, 1 week before admission), mecobalamin (500ug, qd, 2 weeks after admission), and placebo treatment with the same appearance as liruzole (normal saline
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old; 2. Spinal cord injury ASIA grade A-D injury; 3. Within 48h after injury; 4. Able to cooperate with the completion of standardized neurological examination of ISNCSCI standards (including patients on ventilators) willing and able to participate in the follow-up of this study trial; 5. MRI scan of the injury area to exclude tumor, tuberculosis and other lesions. 6. Women of childbearing potential must have a negative serum ß-hCG pregnancy test or a negative urine pregnancy test.
Exclusion criteria
Exclusion criteria: 1. Have serious opportunistic infections or opportunistic tumors; 2. Abnormal blood routine examination (white blood cell < 3×109/L, hemoglobin < 90g/L, neutrophil < 1.5×109/L, platelet < 75×109/L); 3. Have a clear liver disease (positive for hepatitis B surface antigen/HCV antibody), or abnormal liver function test (alanine aminotransferase and/or glutamate aminotransferase exceeding the upper limit of normal value by 2 times, or total bilirubin exceeding the upper limit of normal value by 2 times); 4. Renal insufficiency (glomerular filtration rate < 70ml/min or creatinine exceeding the upper limit of normal value); 5. Patients with more serious chronic diseases, metabolic diseases (such as diabetes), neurological and psychiatric diseases and neurotransmitter-related diseases (such as epilepsy, Parkinson's, etc.), active bleeding, severe hypertension, severe thrombocytopenia, hyperkalemia; 6. Neurological damage caused by other tissues and organs; 7. Concomitant severe head injury as defined by Glasgow Coma Scale score = 14, with head CT showing clinically significant abnormalities (head CT is only considered by the investigator to be required in patients with suspected brain injury). 8. Participated in a clinical trial of another investigational drug or device within the past 30 days. 9. Hypersensitivity to riluzole or any of its components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| American Spinal Injury Association impairment scale;Somatosensory evoked potential (SEP) and Motor evoked potential (MEP);Functional Independence Measure;Spinal Cord Independence Measure;Waiking Index for Spinal Cord Injury;Digital Radiography; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs;Magnetic Resonance Imaging;Computed Tomography ; | — |
Countries
China
Contacts
Public ContactJin Fan
Jiangsu Province Hospital
Outcome results
None listed