Spontaneous Intracerebral Hemorrhage
Conditions
Interventions
Sponsors
First Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age greater than 18 years and less than 80 years; 2. Confirmed by computed tomography as acute intracerebral hemorrhage; 3. Hospitalized within 24 hours after the onset of intracerebral hemorrhage; 4. GCS score > 5 points or NIHSS score < 21 points upon admission.
Exclusion criteria
Exclusion criteria: 1. Hemorrhage definitively attributed to trauma, aneurysm, or tumoral stroke (i.e., non-spontaneous intracerebral hemorrhage). 2. Presence of intraventricular extension of the hematoma. 3. Scheduled for surgical hematoma evacuation. 4. History of significant pre-existing disability (modified Rankin Scale score >3). 5. Severe renal disease (i.e., renal dysfunction requiring dialysis) or estimated glomerular filtration rate (eGFR) 3 times the upper limit of normal (ULN) or total bilirubin >2 times ULN. 7. Pregnancy or lactation. 8. Acute ST-elevation myocardial infarction, decompensated heart failure, cardiac arrest, acute coronary syndrome, or known acute coronary syndrome, acute myocardial infarction, or coronary intervention within the past 3 months. 9. Treatment with Sivelestat Sodium for acute lung injury/COPD within the past 7 days. 10. Known hypersensitivity or allergy to Sivelestat Sodium. 11. Life expectancy less than 3 months due to conditions other than the current intracerebral hemorrhage. 12. Concurrent participation in another interventional clinical trial involving investigational drug therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse functional outcomes at 90 days after onset; | — |
Secondary
| Measure | Time frame |
|---|---|
| The absolute volume of the hematoma (unit: mL) on the 3rd and 7th day after the onset of the disease and the changes from the baseline.;Parameters of pericerebral edema on days 3 and 7 after onset: including absolute volume (PHE), relative volume (rPHE), edema spread distance (EED), peak volume and rate of increase, etc.;Pneumonia incidence during hospitalization; | — |
Countries
China
Contacts
Public ContactYang Guang
First Affiliated Hospital of Harbin Medical University
Outcome results
None listed