Clinical trial NCT06242938: Early Intensive Antihypertensive Treatment in High-Risk Population of intraCerebral Hemorrhage ExpanSion Predicted by Artificial Intelligence
Official title: Early Intensive Antihypertensive Treatment in High-risk Population of Intracerebral Hemorrhage Expansion Predicted by Artificial Intelligence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Hemorrhage
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Death or severe disability (modified Rankin Scale 3-6) at 90 days
timeFrame: 90 days
Secondary outcomes:
measure: Hematoma expansion within 24 hours
timeFrame: 24 hours
measure: Early neurological deterioration (END) within 24h
timeFrame: 24 hours
measure: Modified Rankin Scale (mRS) distribution at 90 days
timeFrame: 90 days
measure: Death at 90 days
timeFrame: Up to 90 days
measure: EuroQol-5 Dimensions (EQ-5D) score at 90 days
timeFrame: 90 days
measure: Death or severe disability (modified Rankin Scale 3-6) at 180 days
timeFrame: Up to 180 days
Other outcomes:
measure: Severe hypoperfusion event
timeFrame: Up to 180 days
measure: Treatment-related serious adverse events (SAEs) during hospitalization
timeFrame: During hospitalization
measure: Death during hospitalization
timeFrame: During hospitalization
Locations:
Study officials:
affiliation: Beijing Tiantan Hospital
name: Kaijiang Kang
role: PRINCIPAL_INVESTIGATOR
References: