Robot-guided blood clot removal and tenecteplase injection for brain bleeding after stroke treatment
Tests robot-guided clot removal plus tenecteplase in adults with bleeding after stroke treatment.
Plain-language title generated from the registry record
Registry title: Robot-Assisted Hematoma Evacuation With Intrahematoma Tenecteplase for Post-Reperfusion PH2 Hemorrhagic Transformation
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07641998, who can take part
Where in China
- Beijing Tiantan Hospital,Capital Medical UniversityBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Tiantan Hospital
- Trial code
- NCT07641998
- Record updated
- 11 June 2026
- Original description
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.Read full original descriptionShow less
A Phase I, Open-Label, Single-Arm Study of Robot-Assisted Stereotactic Minimally Invasive Hematoma Aspiration Followed by Intrahematoma Tenecteplase in Patients With Symptomatic Supratentorial PH2 Hemorrhagic Transformation After Reperfusion Therapy for Acute Ischemic Stroke
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.
Inclusion: •. 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.
Exclusion: 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; 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.