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 >= 18 years and 5 or a National Institutes of Health Stroke Scale (NIHSS) score of <21 at the time of admission.
Exclusion criteria
Exclusion criteria: 1. Hemorrhage with a clear cause such as trauma, aneurysm, or tumoral stroke (i.e., non-spontaneous intracerebral hemorrhage); 2. Presence of intraventricular extension of the hematoma; 3. Planned surgical evacuation of the hematoma; 4. History of chronic respiratory failure; 5. History of significant pre-existing disability (modified Rankin Scale score >3); 6. Severe renal disease (i.e., renal dysfunction requiring dialysis) or an estimated glomerular filtration rate (eGFR) of 3 times the upper limit of normal (ULN), or bilirubin >2 times ULN; 8. Pregnancy or lactation; 9. Acute ST-elevation myocardial infarction, decompensated heart failure, cardiac arrest, acute coronary syndrome, known acute coronary syndrome, acute myocardial infarction, or history of coronary intervention within the past 3 months; 10. Treatment with Sivelestat Sodium for acute lung injury/COPD within the past 7 days; 11. Known allergy to Sivelestat Sodium; 12. A life expectancy of less than 3 months due to conditions other than the current intracerebral hemorrhage; 13. Concurrent participation in another clinical trial involving investigational drug therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of stroke-related pneumonia in patients with spontaneous intracerebral hemorrhage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of stroke-associated pneumonia in patients with spontaneous intracerebral hemorrhage (Based on CURB-65 score, PSI score).;Respiratory function indicators: Oxygenation index on day 1 and day 3 after diagnosis.;Complete blood count indicators: White blood cell count on day 1 and day 3 after diagnosis.;Inflammatory markers: C-reactive protein and procalcitonin levels on day 1 and day 3 after diagnosis.;Length of ICU stay;Incidence of adverse reactions during hospitalization (including abnormal liver function, dyspnea, leukopenia, thrombocytopenia, deep vein thrombosis, etc.); | — |
Countries
China
Contacts
Public ContactYang Guang
First Affiliated Hospital of Harbin Medical University
Outcome results
None listed