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.
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.
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.
Single group
Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplase
DrugProcedure: Robot-assisted stereotactic minimally invasive hematoma aspiration and drainage. Using fused CT and/or MRI images, a robot-guided trajectory will be planned to avoid major vessels, eloquent cortex, and vulnerable peri-infarct tissue when feasible. Initial evacuation will be performed with passive drainage or very low-pressure aspiration, avoiding rapid decompression. Catheter position will be confirmed on postoperative CT. Drug: Tenecteplase (TNK) for intrahematoma administration. After a 2-hour postoperative stability CT confirms no rebleeding, the dose will be calculated as residual hematoma volume × 0.009 mg/mL, diluted to 1 mL with sterile water for injection, instilled through the indwelling catheter, and followed by a 3mL normal saline flush. The catheter will be clamped for 2 hours and then reopened for gravity drainage. TNK will be given once every 24 hours for up to 3 doses.
Symptomatic rebleeding rate
Symptomatic rebleeding is defined as an increase in hematoma volume of more than 6 mL or more than 33% compared with the immediate postoperative CT or the previous study CT, occurring at the original hematoma cavity or catheter tract, together with neurological worsening defined as an NIHSS increase of 4 points or more or a GCS decrease of 2 points or more.
Target hematoma reduction rate
Proportion of participants with residual hematoma volume less than 15 mL or less than 33% of baseline hematoma volume on the end-of-treatment CT scan.
Technical success of catheter placement
Successful placement of the catheter tip within 3 mm of the planned target on postoperative imaging.
Residual hematoma volume
Residual hematoma volume measured by CT using ABC/2 or a prespecified volumetric method.
Proportion achieving residual hematoma ≤10 mL
Participants meeting the treatment-completion target for catheter removal or treatment termination.
Any radiographic rebleeding
Any increase in hematoma volume meeting protocol imaging criteria regardless of clinical symptoms.
Procedure-related SAES
Procedure-related SAES
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
