Robot-Assisted Hematoma Evacuation With Intrahematoma Tenecteplase for Post-Reperfusion PH2 Hemorrhagic Transformation

Other illness

• Infratentorial hemorrhage, including brainstem or cerebellar hemorrhage.
• Large malignant hemispheric infarction in which the dominant cause of mass effect is ischemic edema rather than hematoma, or clear need for decompressive craniectomy as first-line treatment.
• Hemorrhage primarily attributable to aneurysm, arteriovenous malformation, dural arteriovenous fistula, moyamoya disease, tumor, trauma, or another structural lesion; or hemorrhage caused predominantly by a procedural vascular injury unrelated to thrombolysis-associated hemorrhagic transformation.
• Intraventricular hemorrhage requiring separate emergency surgical treatment as the dominant lesion.
• Irreversible brainstem failure, bilateral fixed and dilated pupils, or GCS score of 4 or less.
• Imaging evidence of active bleeding or markedly high rebleeding risk, such as spot sign, if judged unsafe for catheter aspiration.
• Severe hepatic, renal, cardiac, respiratory, or hematologic illness likely to confound assessment or markedly increase procedural risk.
• Known allergy or hypersensitivity to alteplase or tenecteplase.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.

Other

• HI1, HI2, or PH1 hemorrhagic transformation without clinically relevant mass effect.
• Ongoing hematoma expansion on stability CT, defined as growth of 6 mL or more.
• Need for long-term anticoagulation that cannot be safely interrupted during the first 30 days after treatment.
• No safe robot-planned stereotactic trajectory to the hematoma cavity.
• Pregnancy or breastfeeding.
• Participation in another interventional clinical trial.

• •. Age 18 years or older and younger than 80 years.
• Prestroke modified Rankin Scale score of 0 to 2.
• Acute ischemic stroke treated with reperfusion therapy (standard-dose intravenous thrombolysis using alteplase or tenecteplase, or mechanical thrombectomy or any other endovascular reperfusion procedure for the index stroke).
• CT-confirmed symptomatic PH2 hemorrhagic transformation according to ECASS criteria in a supratentorial deep or lobar location, with hematoma-related mass effect and/or midline shift.
• Hematoma volume 20 to 80 mL measured by ABC/2 method.
• Neurological deterioration attributed to hemorrhagic transformation, defined as an NIHSS increase of 4 points or more from the best post-thrombolysis status or a GCS decrease of 2 points or more.
• At least one repeat stability CT scan obtained 6 hours or more after the diagnostic CT showing no ongoing rapid expansion, defined as hematoma growth less than 6 mL.
• Planned robot-assisted stereotactic minimally invasive puncture/aspiration within 24 hours after the diagnostic CT.
• Completion of intravenous thrombolytic infusion at least 4 hours before final preprocedure assessment, with protocol-based reversal/correction of coagulopathy as needed.
• Preprocedure coagulation thresholds achieved after reversal/correction: INR \< 1.4 or less, and fibrinogen \> 1.6 g/L.
• Systolic blood pressure 180 mmHg or less maintained for at least 6 hours before the procedure.
• Written informed consent provided by the participant or legally authorized representative.