Acute spontaneous supratentorial icerebral hemorrhage
Conditions
Interventions
Control group:Normal saline is intermittently pumped intravenously
Experimental group:Glyceryl trinitrate is intermittently pumped intravenously
Sponsors
Beijing Luhe Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80; 2. Patients with spontaneous supratentorial cerebral hemorrhage confirmed by non-contrast CT scan within 24-48 hours of symptom onset, who can receive treatment within 48 hours of symptom onset. 3. No significant hematoma enlargement (defined as >=12.5 mL or >=33% increase) was observed on cranial CT performed 24–48 hours post-onset compared to baseline cranial CT within 24 hours post-onset. The two cr anial CT scans must be performed at least 6 hours apart, and the 24–48-hour scan must indicate a hematoma volume of 10–30 mL. 4.Glasgow Coma Scale (GCS) score >8 at baseline; 5. Baseline NIHSS score >=6 and <= 20; 6. Agreed to participate in this study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Secondary intracerebral hemorrhage, including hemorrhagic transformation after infarction, hemorrhage following intravenous thrombolysis or mechanical thrombectomy, anticoagulant-associated intracerebral hemorrhage, traumatic brain injury, and hemorrhage secondary to any known structural alteration (such as arteriovenous malformation, aneurysm, intracranial tumor, or venous sinus thrombosis); 2. Intracerebral hemorrhage ruptures into the ventricles or subarachnoid space; 3. Surgical treatment is planned for cerebral hemorrhage; 4. Cranial imaging studies indicate midline shift (>10mm) or formation of cerebral herniation; 5. Vital signs are unstable or blood pressure is low (180 mmHg despite medication); 13. Researchers believe other potential factors that may influence the trial and render participants unsuitable for inclusion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematoma enlargement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a mRS score of 0-2 at 90 days after randomization;Adverse events/serious adverse events reported by investigators at 90 days post-randomization;Volume change of perihemorrhagic edema 7 days after randomization;Change in baseline NIHSS scores compared 7 days after randomization;Hypotension within 7 days after randomization;Vascular-related mortality at 90 days after randomization;Proportion of subjects with a modified Rankin Scale (mRS) score of 0-2 at 30 days after randomization;Change in baseline NIHSS scores compared 72 hours after randomization;The absorption percentage of cerebral hemorrhage 7 days after randomization;Proportion of subjects with a mRS score of 0-3 at 90 days after randomization;Changes in hematoma volume at 7 days after randomization;All-cause mortality at 90 days after randomization;Proportion of subjects with a mRS score of 0-3 at 30 days after randomization;Headache within 7 days after randomization;Changes in cerebral blood flow perfusion and hemodynamics in the hemorrhagic area 7 days after randomization;Distribution of mRS Scores at 30 days after randomization;Combined vascular events (including stroke and vascular death) at 90 days after randomization;Distribution of mRS Scores at 90 days after randomization; | — |
Countries
China
Contacts
Public ContactGuangge Peng
Beijing Luhe Hospital, Capital Medical University
Outcome results
None listed