Early Intensive Antihypertensive Treatment in High-Risk Population of intraCerebral Hemorrhage ExpanSion Predicted by Artificial Intelligence

Launched by BEIJING TIANTAN HOSPITAL · Feb 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether early and intensive treatment to lower blood pressure can help patients who have experienced a type of bleeding in the brain called intracerebral hemorrhage (ICH). The trial specifically focuses on patients who are at high risk of their bleeding getting worse, as predicted by an artificial intelligence tool. The main goals are to see if this early treatment is effective and safe for these patients.

To be eligible for this trial, participants must be at least 18 years old and arrive at the hospital within six hours of their symptoms starting. They should have a specific type of brain bleed confirmed by a CT scan and meet certain health criteria, including having a higher blood pressure after the bleeding occurs. If they join the trial, patients will receive intensive blood pressure treatment soon after arriving at the hospital, with the aim of keeping their blood pressure within a target range for a week. This trial is not yet recruiting participants, but it could provide important insights into better treatments for people with severe brain bleeds.

Gender

ALL

Eligibility criteria

• 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.