[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643206":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":45,"collaborators":19,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":70,"whyStopped":19,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplase","EXPERIMENTAL","Participants will undergo robot-assisted stereotactic minimally invasive puncture\u002Faspiration with indwelling catheter drainage. After a postoperative stability CT confirms no rebleeding, intrahematoma tenecteplase will be administered through the catheter.\n\nProcedure: Robot-assisted stereotactic minimally invasive hematoma aspiration and drainage. Using fused CT and\u002For 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.",[13],"Drug: Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplase",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Procedure: Robot-assisted stereotactic minimally invasive hematoma aspiration and drainage. Using fused CT and\u002For 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.\n\nDrug: 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\u002FmL, 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.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Kaijiang Kang, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","+86 18210554710","kangkaijiang678@126.com",[30],{"facility":31,"status":19,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Beijing Tiantan Hospital, Capital Medical University","Beijing","Beijing Municipality","100070","China","CN",{"type":38,"coordinates":39},"Point",[40,41],116.39723,39.9075,{"lat":41,"lon":40},[44],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},{"type":23,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Kaijiang Kang","Dr","100643206","phase-1-robot-assisted-hematoma-evacuation-with-intrahematoma-tenecteplase-for-post-reperfusion-ph2-hemorrhagic-transformation-100643206",false,"NCT07641998","Robot-Assisted Hematoma Evacuation With Intrahematoma Tenecteplase for Post-Reperfusion PH2 Hemorrhagic Transformation","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","REPORT","Inclusion Criteria:\n\n•. Age 18 years or older and younger than 80 years.\n\n* Prestroke modified Rankin Scale score of 0 to 2.\n* 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).\n* CT-confirmed symptomatic PH2 hemorrhagic transformation according to ECASS criteria in a supratentorial deep or lobar location, with hematoma-related mass effect and\u002For midline shift.\n* Hematoma volume 20 to 80 mL measured by ABC\u002F2 method.\n* 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.\n* 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.\n* Planned robot-assisted stereotactic minimally invasive puncture\u002Faspiration within 24 hours after the diagnostic CT.\n* Completion of intravenous thrombolytic infusion at least 4 hours before final preprocedure assessment, with protocol-based reversal\u002Fcorrection of coagulopathy as needed.\n* Preprocedure coagulation thresholds achieved after reversal\u002Fcorrection: INR \\\u003C 1.4 or less, and fibrinogen \\> 1.6 g\u002FL.\n* Systolic blood pressure 180 mmHg or less maintained for at least 6 hours before the procedure.\n* Written informed consent provided by the participant or legally authorized representative.\n\nExclusion Criteria:\n\n* HI1, HI2, or PH1 hemorrhagic transformation without clinically relevant mass effect.\n* Infratentorial hemorrhage, including brainstem or cerebellar hemorrhage.\n* 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.\n* 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.\n* Intraventricular hemorrhage requiring separate emergency surgical treatment as the dominant lesion.\n* Irreversible brainstem failure, bilateral fixed and dilated pupils, or GCS score of 4 or less.\n* Ongoing hematoma expansion on stability CT, defined as growth of 6 mL or more.\n* Imaging evidence of active bleeding or markedly high rebleeding risk, such as spot sign, if judged unsafe for catheter aspiration.\n* Need for long-term anticoagulation that cannot be safely interrupted during the first 30 days after treatment.\n* No safe robot-planned stereotactic trajectory to the hematoma cavity.\n* Severe hepatic, renal, cardiac, respiratory, or hematologic illness likely to confound assessment or markedly increase procedural risk.\n* Pregnancy or breastfeeding.\n* Known allergy or hypersensitivity to alteplase or tenecteplase.\n* Participation in another interventional clinical trial.\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.","ALL","18 Years","80 Years",{"count":60,"type":61},20,"ESTIMATED","INTERVENTIONAL",[64],"PHASE1","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.",[67],"Hemorrhagic Transformation Stroke",[69],"tenecteplase，Minimally Invasive Surgery，hematoma aspiration，Hemorrhagic Transformation，post-reperfusion","NOT_YET_RECRUITING","2026-06-06",{"date":73,"type":74},"2026-06-11","ACTUAL",{"date":76,"type":61},"2026-06-10",{"date":78,"type":61},"2026-12-30",{"name":5,"class":6},1]