A PILOT TRIAL of a DISPOSABLE INTRACEREBRAL ASPIRATION ENDOSCOPE for the TREATMENT of INTRACEREBRAL HEMATOMA（FAST-HET）

Inclusion criteria

• Age ≥ 18 and ≤ 80 years old;
• Spontaneous intracerebral hemorrhage;
• Hemorrhage located in the supratentorial subcortical or basal ganglia region;
• Hematoma volume ≥ 30ml and ≤ 80ml;
• Able to undergo surgery within 72 hours after onset;
• GCS score of 5 to 14;
• The subject themselves and/or their authorized representative can understand the purpose of the study, agree to participate, and sign the informed consent form.

Exclusion criteria

• History of intracerebral hemorrhage within the past year;
• Traumatic intracerebral hemorrhage;
• Multiple intracerebral hemorrhages;

Note: Hemorrhage in the supratentorial subcortical or basal ganglia region that extends into the ventricles is not considered multiple hemorrhages and can be included.

• Known or suspected intracerebral hemorrhage caused by tumors, aneurysms, vascular malformations, hemorrhagic transformation of ischemic stroke, cerebral venous thrombosis, etc.;
• Formation of brain herniation;
• Severe neurological or psychiatric disorders before onset (such as epilepsy, Alzheimer's disease, Parkinson's disease, schizophrenia, depression, etc.);
• mRS score ≥ 3 before onset;
• Use of anticoagulants or antiplatelet drugs within 14 days before onset, or the need for long-term use of anticoagulants or antiplatelet drugs, or other factors causing coagulation dysfunction;
• Platelet count less than 100 × 10^3/μL or international normalized ratio (INR) greater than 1.4;
• Active bleeding present, such as gastrointestinal bleeding, respiratory bleeding, or subcutaneous hematoma;
• Uncontrolled hypertension that cannot be managed with medication (systolic blood pressure > 220 mmHg or diastolic blood pressure > 120 mmHg after medication upon admission);
• Severe systemic diseases that cannot tolerate surgery, such as severe liver or kidney dysfunction;
• Women of childbearing age who are pregnant or breastfeeding;
• Currently participating in any drug or device research, or planning to participate in other drug or device clinical trials;
• Life expectancy ≤ 1 year;
• Other situations where the researcher deems the subject unsuitable for the study.