Early Intensive Antihypertensive Treatment in High-Risk Population of intraCerebral Hemorrhage ExpanSion Predicted by Artificial Intelligence
- Conditions
- Cerebral Hemorrhage
- Interventions
- Procedure: Early intensive antihypertensive treatment
- Registration Number
- NCT06242938
- Lead Sponsor
- Beijing Tiantan Hospital
- Brief Summary
The goal of this clinical trial is to clarify the efficacy, safety and feasibility of early intensive antihypertensive treantment in intracerebral hemorrhage (ICH) patients at high risk of hematoma expansion based on artificial intelligence prediction.
The main question it aims to answer are:
* Can ICH patients at high risk of hematoma expansion based on artificial intelligence prediction benefit from early intensive antihypertensive treatment?
* Is early intensive antihypertensive treatment safe to patients at high risk of hematoma expansion based on artificial intelligence prediction.
Participants will accept intensive antihypertensive treatment (target systolic blood pressure: 130-140mmHg) at early stage (within 1 hour after randomization) of cerebral hemorrhage and maitain the target blood pressure for 7 days.
Researchers will compare standard treatment group (target systolic blood pressure 140-180mmHg after randomization) to see if intensive antihypertensive treatment can improve the outcome of patients with ICH.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 680
- ① Age ≥ 18 years;
- ② Arrival at the hospital within 6h of onset, able to complete randomization and receive antihypertensive treatment within 1h of arrival (if the time of onset is unclear, the last normal time will be used);
- ③ CT-confirmed spontaneous supratentorial brain parenchymal hematoma that can break into the ventricles and subarachnoid space, with a hematoma volume of <60 ml;
- ④ Patients at high risk of hematoma expansion with ≥3 points on the artificial intelligence-based hematoma expansion 5-point prediction score;
- ⑤ GCS >8;
- ⑥ SBP in the range of 150-220 mmHg after onset and before randomization;
- ⑦ Signed informed consent by the patient or legal representative.
- ① Cerebral hemorrhage is caused by known secondary causes such as trauma, tumors, cerebrovascular malformations, and thrombolysis and thrombus extraction
- ② When the brain parenchyma hemorrhage involves the ventricles, the blood completely fills one lateral ventricle or more than half of both lateral ventricles.
- ③ The hematoma of previous intracerebral hemorrhage has not yet been absorbed
- ④ Surgical treatment is planned within 24 hours
- ⑤ Combination of conditions known to be inappropriate for intensive blood pressure lowering (e.g., severe carotid artery stenosis, vertebral artery or intracranial artery stenosis, smoky or Takayasu's arteritis, and severe heart valve stenosis)
- ⑥Combination of known well-defined indications requiring a more aggressive antihypertensive treatmenr, such as hypertensive encephalopathy or aortic coarctation
- ⑦ Known allergy to antihypertensive drugs
- ⑧Known allergy to antihypertensive drugs (i.e., warfarin with INR > 1.5 or other anticoagulant drugs within the past 24 hours).
- ⑨ With platelet counts less than 50,000/mm3.
- ⑩ Disability due to prior illness mRS ≥ 3
- ⑪ Pregnancy status or within 30 days after delivery
- ⑫ Severe heart or liver disease, severe renal insufficiency (eGFR <30 ml/min) or malignant tumor with life expectancy <3 months.
- ⑬ Currently participating in other interventional clinical trials
- ⑭ Informed consent cannot be obtained.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early intensive antihypertensive treatment group Early intensive antihypertensive treatment 1. Treatment starts within 1 hour after randomization 2. SBP target:130-140 mmHg within 1 hour after treatment 3. Under the guidance of medication, the researchers can independently select oral + intravenous antihypertensive medications
- Primary Outcome Measures
Name Time Method Death or severe disability (modified Rankin Scale 3-6) at 90 days 90 days Death or severe disability is defined as modified Rankin Scale (mRS) 3-6. The mRS is a scale used to measure the degree of disability caused by stroke or other neurological conditions. It ranges from 0 (no symptoms) to 6 (death). The lower the score, the less severe the disability.
- Secondary Outcome Measures
Name Time Method Hematoma expansion within 24 hours 24 hours Hematoma volume increase ≥6ml on follow up non-contrast CT.
Early neurological deterioration (END) within 24h 24 hours Within 24 hours after onset, NIHSS increase ≥4 or GCS decreased ≥2 (compared to baseline);
Death or severe disability (modified Rankin Scale 3-6) at 180 days Up to 180 days Death or severe disability is defined as modified Rankin Scale (mRS) 3-6. The mRS is a scale used to measure the degree of disability caused by stroke or other neurological conditions. It ranges from 0 (no symptoms) to 6 (death). The lower the score, the less severe the disability.
Death at 90 days Up to 90 days Modified Rankin Scale (mRS) distribution at 90 days 90 days The mRS is a scale used to measure the degree of disability caused by stroke or other neurological conditions. It ranges from 0 (no symptoms) to 6 (death). The lower the score, the less severe the disability.
EuroQol-5 Dimensions (EQ-5D) score at 90 days 90 days The EQ-5D is a standardized instrument for measuring generic health status developed by the EuroQol Group. It assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three levels: no problems, some problems, and severe problems. The EQ-5D scores range from -0.594 to 1, where 1 represents full health and 0 represents death. Lower scores indicate poorer health. The EQ-5D is commonly used in economic evaluations of health care interventions to assess quality-adjusted life years (QALYs).