Hemorrhagic Transformation StrokePhase 1REPORTNCT07641998
Robot-Assisted Hematoma Evacuation With Intrahematoma Tenecteplase for Post-Reperfusion PH2 Hemorrhagic Transformation
A Phase 1 study testing Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplase in people with Hemorrhagic Transformation Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemorrhagic Transformation Stroke
- What is being tested?
- Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2026to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •. 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Kaijiang Kang, MD, +86 18210554710, kangkaijiang678@126.com
About this study
Official title: 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.
Read the detailed description
Symptomatic intracranial hemorrhage after reperfusion therapy is one of the most devastating complications of acute ischemic stroke and is associated with high mortality, especially in patients with PH2 hemorrhagic transformation and substantial mass effect. Current management is largely supportive and includes discontinuation of antithrombotic agents, correction of coagulation abnormalities, blood pressure control, and intracranial pressure management. However, medical treatment does not remove the hematoma or reverse the local toxic and space-occupying effects of blood products.
Open craniotomy may be lifesaving in selected patients, but it may also cause additional injury to already ischemic and vulnerable brain tissue. Robot-assisted stereotactic minimally invasive puncture and aspiration may provide a less disruptive method to evacuate hematoma, reduce mass effect, and preserve surrounding tissue. A prior phase I neuronavigation-assisted minimally invasive puncture study in spontaneous deep intracerebral hemorrhage identified 0.009 mg/mL of hematoma-volume-adjusted tenecteplase as the highest tested dose with acceptable safety and the greatest mean hematoma clearance. Because the present trial targets a different and higher-risk population, namely post-reperfusion therapy PH2 hemorrhagic transformation, the study remains phase I in intent but uses a fixed dose rather than a dose-escalation design.
This is a prospective, open-label, single-arm phase I trial enrolling 20 participants with symptomatic supratentorial PH2 hemorrhagic transformation after reperfusion therapy (intravenous thrombolysis, with or without bridging mechanical thrombectomy). Eligible hematomas may be deep or lobar and must be associated with clinically relevant neurological worsening and hematoma-related mass effect. Before puncture, all participants must undergo protocol-based correction of coagulation abnormalities and at least one stability CT scan confirming no ongoing rapid expansion. Robot-assisted stereotactic aspiration and catheter placement will then be performed. A repeat CT approximately 2 hours later must confirm no procedure-related rebleeding before intrahematoma tenecteplase is started.
Tenecteplase will be administered once daily through the indwelling catheter at a fixed dose of 0.009 mg/mL of residual hematoma volume, for up to 3 doses. Each dose will be diluted to 1 mL with sterile water for injection, followed by a 3 ml normal saline flush. The catheter will remain clamped for 2 hours and then reopened for drainage. Treatment will stop when any termination criterion is met, including symptomatic rebleeding, radiographic hematoma enlargement, residual hematoma of 10 mL or less, or completion of 3 doses.
The primary objective is safety, particularly symptomatic rebleeding within 72 hours after the procedure or first tenecteplase dose, defined as clinically relevant hematoma expansion at the original cavity or catheter tract accompanied by neurological deterioration. The main efficacy and feasibility objectives are to determine whether the procedure achieves protocol-defined hematoma reduction-residual hematoma volume<15 mL or <33% of baseline volume by end-of-treatment CT-and accurate catheter placement within 3 mm of the planned target on immediate postoperative imaging. Secondary outcomes include residual hematoma volume at Day 7 or end of treatment, the proportion of participants achieving residual hematoma ≤10 mL, any radiographic rebleeding through Day 7, and procedure-related serious adverse events（SAE） through Day 7.
- Conditions
- Hemorrhagic Transformation Stroke
- Being tested
- Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplase
- Keywords
- tenecteplase，Minimally Invasive Surgery，hematoma aspiration，Hemorrhagic Transformation，post-reperfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplaseDrug
Procedure: 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.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplase | Experimental | Participants will undergo robot-assisted stereotactic minimally invasive puncture/aspiration with indwelling catheter drainage. After a postoperative stability CT confirms no rebleeding, intrahematoma tenecteplase will be administered through the catheter.
Procedure: 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. Receives: Drug: Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through 72 hours after procedure or first TNK dose
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.
Measured: End of treatment, defined as within 7 days after procedure or before catheter removal
Technical success of catheter placement
Successful placement of the catheter tip within 3 mm of the planned target on postoperative imaging.
Measured: Immediate postoperative CT, within 24 hours after procedure
Secondary outcomes (4)
Residual hematoma volume
Residual hematoma volume measured by CT using ABC/2 or a prespecified volumetric method.
Measured: Day 7, or at end of treatment
Proportion achieving residual hematoma ≤10 mL
Participants meeting the treatment-completion target for catheter removal or treatment termination.
Measured: Day 7, or at end of treatment
Any radiographic rebleeding
Any increase in hematoma volume meeting protocol imaging criteria regardless of clinical symptoms.
Measured: Through Day 7
Procedure-related SAES
Procedure-related SAES
Measured: Through Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start10 Jun 2026 (estimated)
- Primary completion10 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hemorrhagic Transformation StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaijiang Kang, Beijing Tiantan Hospital
- Investigators
- Kaijiang Kang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641998
- Sponsor's protocol ID
- KY2024-386-02
- Acronym
- REPORT
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification.
Publications
Ha HJ, Ryu WS, Sunwoo L, Lee M, Kang K, Kim JG, Lee SJ, Cha JK, Park TH, Lee JY, Lee K, Kwon DH, Lee J, Park HK, Hong KS, Lee M, Oh MS, Yu KH, Gwak DS, Kim DE, Kim H, Kim JT, Kim JG, Choi JC, Kim WJ, Weon YC, Kwon JH, Yum KS, Shin DI, Hong JH, Sohn SI, Lee SH, Kim C, Jeong HB, Park KY, Kim CK, Kang J, Kim JY, Bae HJ, Lin L, Parsons M, Kim BJ. Clinical Impact of Postrecanalization Hemorrhagic Transformation and Its Prediction Using Baseline Noncontrast CT. Stroke. 2026 May;57(5):1325-1335. doi: 10.1161/STROKEAHA.125.053938. Epub 2026 Mar 9.
PubMed 41797706Wu Z, Wang M, Bai X, Tang J, Ni Y, Zhao S, Wang P, He Q, Huo R, Jiao Y, Wang D, Cao Y. Phase I dose-escalation study of tenecteplase, a third-generation fibrinolytic agent, combined with neuronavigation-assisted stereotactic minimally invasive puncture, in patients with acute spontaneous deep cerebral haemorrhage. Stroke Vasc Neurol. 2026 Jun 29;11(3):296-302. doi: 10.1136/svn-2025-004389.
PubMed 40992931Hanley DF, Thompson RE, Rosenblum M, Yenokyan G, Lane K, McBee N, Mayo SW, Bistran-Hall AJ, Gandhi D, Mould WA, Ullman N, Ali H, Carhuapoma JR, Kase CS, Lees KR, Dawson J, Wilson A, Betz JF, Sugar EA, Hao Y, Avadhani R, Caron JL, Harrigan MR, Carlson AP, Bulters D, LeDoux D, Huang J, Cobb C, Gupta G, Kitagawa R, Chicoine MR, Patel H, Dodd R, Camarata PJ, Wolfe S, Stadnik A, Money PL, Mitchell P, Sarabia R, Harnof S, Barzo P, Unterberg A, Teitelbaum JS, Wang W, Anderson CS, Mendelow AD, Gregson B, Janis S, Vespa P, Ziai W, Zuccarello M, Awad IA; MISTIE III Investigators. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. Lancet. 2019 Mar 9;393(10175):1021-1032. doi: 10.1016/S0140-6736(19)30195-3. Epub 2019 Feb 7.
PubMed 30739747Zhou X, Chen J, Li Q, Ren G, Yao G, Liu M, Dong Q, Guo J, Li L, Guo J, Xie P. Minimally invasive surgery for spontaneous supratentorial intracerebral hemorrhage: a meta-analysis of randomized controlled trials. Stroke. 2012 Nov;43(11):2923-30. doi: 10.1161/STROKEAHA.112.667535. Epub 2012 Sep 18.
PubMed 22989500
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07641998
- Acronym / sponsor ID
- REPORT / KY2024-386-02
- Conditions
- Hemorrhagic Transformation Stroke
- Keywords
- tenecteplase，Minimally Invasive Surgery，hematoma aspiration，Hemorrhagic Transformation，post-reperfusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Symptomatic intracranial hemorrhage after reperfusion therapy is one of the most devastating complications of acute ischemic stroke and is associated with high mortality, especially in patients with PH2 hemorrhagic transformation and substantial mass effect. Current management is largely supportive and includes discontinuation of antithrombotic agents, correction of coagulation abnormalities, blood pressure control, and intracranial pressure management. However, medical treatment does not remove the hematoma or reverse the local toxic and space-occupying effects of blood products.
Open craniotomy may be lifesaving in selected patients, but it may also cause additional injury to already ischemic and vulnerable brain tissue. Robot-assisted stereotactic minimally invasive puncture and aspiration may provide a less disruptive method to evacuate hematoma, reduce mass effect, and preserve surrounding tissue. A prior phase I neuronavigation-assisted minimally invasive puncture study in spontaneous deep intracerebral hemorrhage identified 0.009 mg/mL of hematoma-volume-adjusted tenecteplase as the highest tested dose with acceptable safety and the greatest mean hematoma clearance. Because the present trial targets a different and higher-risk population, namely post-reperfusion therapy PH2 hemorrhagic transformation, the study remains phase I in intent but uses a fixed dose rather than a dose-escalation design.
This is a prospective, open-label, single-arm phase I trial enrolling 20 participants with symptomatic supratentorial PH2 hemorrhagic transformation after reperfusion therapy (intravenous thrombolysis, with or without bridging mechanical thrombectomy). Eligible hematomas may be deep or lobar and must be associated with clinically relevant neurological worsening and hematoma-related mass effect. Before puncture, all participants must undergo protocol-based correction of coagulation abnormalities and at least one stability CT scan confirming no ongoing rapid expansion. Robot-assisted stereotactic aspiration and catheter placement will then be performed. A repeat CT approximately 2 hours later must confirm no procedure-related rebleeding before intrahematoma tenecteplase is started.
Tenecteplase will be administered once daily through the indwelling catheter at a fixed dose of 0.009 mg/mL of residual hematoma volume, for up to 3 doses. Each dose will be diluted to 1 mL with sterile water for injection, followed by a 3 ml normal saline flush. The catheter will remain clamped for 2 hours and then reopened for drainage. Treatment will stop when any termination criterion is met, including symptomatic rebleeding, radiographic hematoma enlargement, residual hematoma of 10 mL or less, or completion of 3 doses.
The primary objective is safety, particularly symptomatic rebleeding within 72 hours after the procedure or first tenecteplase dose, defined as clinically relevant hematoma expansion at the original cavity or catheter tract accompanied by neurological deterioration. The main efficacy and feasibility objectives are to determine whether the procedure achieves protocol-defined hematoma reduction-residual hematoma volume<15 mL or <33% of baseline volume by end-of-treatment CT-and accurate catheter placement within 3 mm of the planned target on immediate postoperative imaging. Secondary outcomes include residual hematoma volume at Day 7 or end of treatment, the proportion of participants achieving residual hematoma ≤10 mL, any radiographic rebleeding through Day 7, and procedure-related serious adverse events（SAE） through Day 7.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplase | Experimental | Drug: Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplaseParticipants will undergo robot-assisted stereotactic minimally invasive puncture/aspiration with indwelling catheter drainage. After a postoperative stability CT confirms no rebleeding, intrahematoma tenecteplase will be administered through the catheter. Procedure: 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- •. 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplaseProcedure: 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. | Drug | Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplase |
Primary outcome
Symptomatic rebleeding rate
Time frame: Through 72 hours after procedure or first TNK dose
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
Time frame: End of treatment, defined as within 7 days after procedure or before catheter removal
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
Time frame: Immediate postoperative CT, within 24 hours after procedure
Successful placement of the catheter tip within 3 mm of the planned target on postoperative imaging.
4 secondary outcomes
Residual hematoma volume
Time frame: Day 7, or at end of treatment
Proportion achieving residual hematoma ≤10 mL
Time frame: Day 7, or at end of treatment
Any radiographic rebleeding
Time frame: Through Day 7
Procedure-related SAES
Time frame: Through Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 41797706Ha HJ, Ryu WS, Sunwoo L, Lee M, Kang K, Kim JG, Lee SJ, Cha JK, Park TH, Lee JY, Lee K, Kwon DH, Lee J, Park HK, Hong KS, Lee M, Oh MS, Yu KH, Gwak DS, Kim DE, Kim H, Kim JT, Kim JG, Choi JC, Kim WJ, Weon YC, Kwon JH, Yum KS, Shin DI, Hong JH, Sohn SI, Lee SH, Kim C, Jeong HB, Park KY, Kim CK, Kang J, Kim JY, Bae HJ, Lin L, Parsons M, Kim BJ. Clinical Impact of Postrecanalization Hemorrhagic Transformation and Its Prediction Using Baseline Noncontrast CT. Stroke. 2026 May;57(5):1325-1335. doi: 10.1161/STROKEAHA.125.053938. Epub 2026 Mar 9.
- Background: PubMed 40992931Wu Z, Wang M, Bai X, Tang J, Ni Y, Zhao S, Wang P, He Q, Huo R, Jiao Y, Wang D, Cao Y. Phase I dose-escalation study of tenecteplase, a third-generation fibrinolytic agent, combined with neuronavigation-assisted stereotactic minimally invasive puncture, in patients with acute spontaneous deep cerebral haemorrhage. Stroke Vasc Neurol. 2026 Jun 29;11(3):296-302. doi: 10.1136/svn-2025-004389.
- Background: PubMed 30739747Hanley DF, Thompson RE, Rosenblum M, Yenokyan G, Lane K, McBee N, Mayo SW, Bistran-Hall AJ, Gandhi D, Mould WA, Ullman N, Ali H, Carhuapoma JR, Kase CS, Lees KR, Dawson J, Wilson A, Betz JF, Sugar EA, Hao Y, Avadhani R, Caron JL, Harrigan MR, Carlson AP, Bulters D, LeDoux D, Huang J, Cobb C, Gupta G, Kitagawa R, Chicoine MR, Patel H, Dodd R, Camarata PJ, Wolfe S, Stadnik A, Money PL, Mitchell P, Sarabia R, Harnof S, Barzo P, Unterberg A, Teitelbaum JS, Wang W, Anderson CS, Mendelow AD, Gregson B, Janis S, Vespa P, Ziai W, Zuccarello M, Awad IA; MISTIE III Investigators. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. Lancet. 2019 Mar 9;393(10175):1021-1032. doi: 10.1016/S0140-6736(19)30195-3. Epub 2019 Feb 7.
- Background: PubMed 22989500Zhou X, Chen J, Li Q, Ren G, Yao G, Liu M, Dong Q, Guo J, Li L, Guo J, Xie P. Minimally invasive surgery for spontaneous supratentorial intracerebral hemorrhage: a meta-analysis of randomized controlled trials. Stroke. 2012 Nov;43(11):2923-30. doi: 10.1161/STROKEAHA.112.667535. Epub 2012 Sep 18.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaijiang Kang, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplase in people with Hemorrhagic Transformation Stroke, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaijiang Kang, MD (+86 18210554710, kangkaijiang678@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic rebleeding rate (time frame: Through 72 hours after procedure or first TNK dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07641998, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.