Cerebral Hemorrhage
Conditions
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.
Interventions
PROCEDUREEarly intensive antihypertensive treatment
1. Treatment starts within 1 hour after randomization 2. SBP target:130-140 mmHg within 1 hour after treatment 3. The researchers can independently select oral + intravenous antihypertensive medications. Any type of antihypertensive drugs can be selected (eg. β-blokers, α-blockers, CCBs, ARBs/ACEIs, diuretic, etc.).
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Death at 90 days | Up to 90 days | — |
| 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). |
| 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. |
| 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); |
Other
| Measure | Time frame | Description |
|---|---|---|
| Death during hospitalization | During hospitalization | — |
| Severe hypoperfusion event | Up to 180 days | Including acute kidney injury, severe hypotension, oliguria, acute myocardial infarction, acute cerebral infarction, etc. |
| Treatment-related serious adverse events (SAEs) during hospitalization | During hospitalization | — |
Contacts
Primary ContactNa Li, MD, PhD
Outcome results
None listed