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

NCT07641998 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: KY2024-386-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hemorrhagic Transformation Stroke

Keywords

tenecteplase，Minimally Invasive Surgery，hematoma aspiration，Hemorrhagic Transformation，post-reperfusion

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Immediate postoperative CT, within 24 hours after procedure

Secondary Outcomes (4)

• Residual hematoma volume

  Day 7, or at end of treatment

• Proportion achieving residual hematoma ≤10 mL

  Day 7, or at end of treatment

• Any radiographic rebleeding

  Through Day 7

• Procedure-related SAES

  Through Day 7

Study Arms (1)

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.

Drug: Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplase

Interventions

Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplase DRUG

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.

Robot-assisted stereotactic hematoma aspiration plus intrahematoma tenecteplase

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (4)

• 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.

  PMID: 41797706 BACKGROUND

• Wu 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. 2025 Sep 24:svn-2025-004389. doi: 10.1136/svn-2025-004389. Online ahead of print.

  PMID: 40992931 BACKGROUND

• Hanley 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.

  PMID: 30739747 BACKGROUND

• Zhou 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.

  PMID: 22989500 BACKGROUND

Study Officials

• Kaijiang Kang, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaijiang Kang, MD

CONTACT

+86 18210554710; kangkaijiang678@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 11, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers with a peer-reviewed biological research proposal. Please contact the PI via email （kangkaijiang678@126.com）to request data access.

Locations

CN (1)