Spontaneous intracerebral hemorrhage
Conditions
Interventions
Test Group:Intensive Blood Pressure Lowering
Control group:Standard Blood Pressure Control
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years. 2. Diagnosis of acute spontaneous intracerebral hemorrhage (ICH): Clinically diagnosed and confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) within 6 hours of symptom onset. Supratentorial hemorrhage: Hematoma volume >= 30 mL and = 10 mL. 3. Neurological status: Glasgow Coma Scale (GCS) score >= 5 at admission. 4. Blood pressure criteria: At least two measurements (taken at least 5 minutes apart) of systolic blood pressure (SBP) between 150 mmHg and 220 mmHg after admission and prior to randomization. 5. urgical indication and timing: Meets the surgical indications recommended by the Chinese Guidelines for the Diagnosis and Treatment of Intracerebral Hemorrhage as assessed by a multidisciplinary team. Planned to undergo surgical hematoma evacuation (including but not limited to craniotomy, neuroendoscopic surgery, or other minimally invasive procedures) within 24 hours of symptom onset. 6. Informed consent: The patient or their legal representative understands and signs the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Ineligible hemorrhage location or type, including brainstem hemorrhage, isolated intraventricular hemorrhage without intraparenchymal hematoma, and multiple or scattered intracerebral hemorrhages. 2. Systolic blood pressure > 220 mmHg. 3. Secondary intracerebral hemorrhage, including but not limited to: hemorrhage clearly associated with anticoagulant, antiplatelet, or thrombolytic therapy; hemorrhage caused by vascular lesions such as aneurysms, arteriovenous malformations, cavernous malformations, moyamoya disease, or dural arteriovenous fistulas; and traumatic intracranial hemorrhage. 4. Contraindications to intensive blood pressure management or conflicts with group assignment: (1) Contraindications to intensive blood pressure lowering: Severe intracranial or carotid artery stenosis; severe aortic stenosis; hypertension secondary to elevated intracranial pressure (i.e., Cushing's response); severe renal failure (or requiring dialysis), etc. (2) Conditions requiring urgent and intensive blood pressure lowering regardless of group assignment: Hypertensive encephalopathy; aortic dissection, etc. 5. Definite contraindications to surgery: (1) End-stage disease, such as bilateral fixed dilated pupils with central respiratory failure due to advanced brain herniation; (2) Severe coagulopathy that cannot be corrected; (3) Other severe systemic diseases precluding tolerance to anesthesia or surgery. 6. Pre-existing severe dementia, disability, or comorbidities interfering with study assessments prior to ICH onset: (1) Severe functional disability prior to the current ICH, defined as modified Rankin Scale (mRS) score >= 3 (e.g., paralysis, aphasia); (2) Known severe dementia; history of ischemic stroke within the past 30 days; (3) Other comorbidities that may significantly interfere with the assessment of neurological outcomes or preclude completion of 90-day follow-up (e.g., advanced malignancy with life expectancy < 6 months, severe decompensated cardiovascular disease, active mental illness). 7. Other: (1) Pregnancy or breastfeeding; (2) Participation in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with modified Rankin Scale (mRS) score of 4–6 at 90 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of dependency at 90 days (mRS score 3–5);Incidence of symptomatic hypotension events;Health-related quality of life at 90 days assessed by EQ-5D;Incidence of acute coronary syndrome within 90 days post-randomization;Incidence of symptomatic ischemic stroke within 7 days post-surgery;All-cause mortality at 90 days; | — |
Countries
China
Contacts
Public ContactZeng Chunyu
Army Medical Center of PLA
Outcome results
None listed