Spinal Cord Injury
Conditions
Interventions
Intervention group:Methylprednisolone + Nafamostat
Control group:Methylprednisolone + placebo
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 ~ 65 years old; Full ability to action; Willing and able to participate in the study follow-up study; 2) Completely thoracolumbar spinal cord injury: Level ASIA-A, T10 - L5 segments; 3) Within 8h after injury; 4) Exclude other lesions through MRI scans of lesions; 5) No other compound injuries in all cases.
Exclusion criteria
Exclusion criteria: 1) Serious opportunistic infections or tumors; 2) Abnormal blood tests (white blood cells <3×10^9/L, hemoglobin <90g/L, neutrophils <1.5×10^9/L, platelets <75×10^9/L); 3) Have a clear liver disease (hepatitis B surface antigen / HCV antibody positive), or abnormal liver function test (alanine aminotransferase and / or aspartate aminotransferase more than 3 times the upper limit of normal or total bilirubin more than 2 times the upper limit of normal); 4) Renal insufficiency (glomerular filtration rate <70ml/min, or creatinine more than the upper limit of normal); 5) With serious chronic diseases, metabolic diseases (such as diabetes mellitus), neurological and psychiatric diseases, active bleeding, severe hypertension, severe thrombocytopenia, hyperkalemia; 6) Pancreatitis Previously; 7) Women in period of pregnant or lactating; 8) allergies or known to the drug ingredients, and allergy to drug of the provisions of this program background; 9) suspected or identified alcohol, drug abuse history; 10) Participated in other drug clinical trials (excluding Chinese medicine) within three months of screening; 11) Other factors that researchers think are not suitable for entering the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASIA spinal cord injury score.;IANR spinal cord injury function evaluation scale;Functional independence measurement scale;Walking index spinal cord injury;Neuroelectrophysiological examination.;Bladder function; | — |
Secondary
| Measure | Time frame |
|---|---|
| Routine examination;Imaging and ultrasonography examination; | — |
Countries
China
Contacts
Public ContactFeng Shiqing
Tianjin Medical University General Hospital
Outcome results
None listed