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

Starting soon · Phase 1

Conditions studied: Hemorrhagic Transformation Stroke

In brief

The purpose of this phase I trial is to evaluate the safety and feasibility of robot-assisted stereotactic minimally invasive hematoma aspiration, followed when eligible by intrahematoma tenecteplase administration, in patients who develop symptomatic supratentorial PH2 hemorrhagic transformation after reperfusion therapy for acute ischemic stroke. The main study questions are whether this strategy is associated with an acceptable early rebleeding risk and whether it can achieve clinically meaningful hematoma reduction with accurate catheter placement and relief of hematoma-related mass effect.

Key facts

Study ID

NCT07641998

Run by

Beijing Tiantan Hospital

People needed

20

Starts

2026-06-10

Expected to finish

2026-12-30

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• . 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.

You may not qualify if…

• HI1, HI2, or PH1 hemorrhagic transformation without clinically relevant mass effect.
• 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.
• Ongoing hematoma expansion on stability CT, defined as growth of 6 mL or more.
• Imaging evidence of active bleeding or markedly high rebleeding risk, such as spot sign, if judged unsafe for catheter aspiration.
• 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.
• Severe hepatic, renal, cardiac, respiratory, or hematologic illness likely to confound assessment or markedly increase procedural risk.
• Pregnancy or breastfeeding.
• Known allergy or hypersensitivity to alteplase or tenecteplase.
• Participation in another interventional clinical trial.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.

Where it is running

• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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