NCT06868511 Neuronavigation-assisted Stereotactic Puncture With Tenecteplase for Acute Intracerebral Hemorrhage
| NCT ID | NCT06868511 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Deep Intracerebral Hemorrhage (ICH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 732 participants |
| Start Date | 2025-04-25 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 732 participants in total. It began in 2025-04-25 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background Minimally invasive puncture surgery followed by thrombolysis has been proven to be an effective approach for managing hypertensive intracerebral hemorrhage. Nevertheless, its impact on improving neurological outcomes remains controversial. The integration of neuronavigation-assisted stereotactic (NAS) technology will significantly help enhance the accuracy of catheter placement, while tenecteplase (TNK), a third-generation thrombolytic agent, with greater potency in lysing platelet-rich clots and heightened specificity for fibrin may improve thrombolysis efficiency. However, the efficacy and safety of combining NAS minimally invasive puncture combined with TNK in reducing disability and mortality rates among patients with acute spontaneous deep intracerebral hemorrhage remain unknown. Aim To evaluate the efficacy and safety of neuronavigation-assisted stereotactic MIPS combined with TNK thrombolysis （NAS-TNK）in reducing disability and mortality in patients with deep hypertensive intracerebral hemorrhage. Design NAS-TNK is a randomized, open-label, outcome-blinded multicenter trial, involving 732 participants with acute basal ganglia or thalamic hemorrhage with a hematoma volume ranging from 20-50 mL. This study will evaluate the efficacy and safety of NAS minimally invasive puncture combined with TNK, administered every 24 hours at a dose of 0.009 mg per milliliter of hematoma volume, compared to participants receiving standard medical care. All patients will be followed up for 180 days. Study outcomes The primary efficacy outcome is the proportion of subjects in the NAS-TNK group with a modified Rankin Scale (mRS) score between 0 and 3 at 180 days. The primary safety outcome is the all-cause death at 30-day. The NAS-TNK study will help improve our understanding of the benefits of NAS minimally invasive puncture combined with TNK in patients with acute spontaneous deep intracerebral hemorrhage. This ongoing research will provide Level I evidence to guide clinicians in managing acute intracerebral hemorrhage treatment options.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years and \<80 years. 2. Symptoms must have manifested within 24 hours prior to the diagnostic CT (dCT) scan. Cases with an indeterminate onset time are excluded. For patients who present symptoms upon sleeping, the last known time they were well should be used. 3. Acute spontaneous deep intracerebral hemorrhage (ICH) occurring in the basal ganglia or thalamus, with a volume between 20-50 mL as measured by ABC/2 method with radiographic imaging (CT, etc.). 4. Glasgow Coma Scale (GCS) score of 5-14. 5. Stability CT scan done at least 6 hours after diagnostic CT showing clot stability (growth\<5 mL as measured by ABC/2 method). 6. Randomization should occur within 6 to 24 hours after the diagnostic CT. 7. Systolic blood pressure (SBP) less than 180 mmHg maintained for a duration of six hours, documented proximate to the randomization time point. 8. Historical Rankin score of 0 or 1. Exclusion Criteria: 1. Lobar or subtentorial hemorrhage, including posterior fossa hemorrhage and cerebellar hemorrhage. 2. Stability CT scan done at least 6 hours after diagnostic CT showing clot instability (growth ≥5 mL as measured by ABC/2 method). 3. Intraventricular hemorrhage necessitating intervention to address mass effect or midline shift attributable to trapped ventricle syndrome secondary to intraventricular hemorrhage (IVH)-related casting. 4. Hemorrhage attributable to other cerebrovascular pathologies, including but not limited to ruptured aneurysm, arteriovenous malformation (AVM), vascular anomalies, moyamoya disease, hemorrhagic transformation of an ischemic infarct, or recurrence of a recent hemorrhage within the past year, as diagnosed through radiographic imaging. 5. Patients presenting with an unstable intracranial mass or progressive intracranial compartment syndrome. 6. Thalamic hemorrhages exhibiting evident extension into the midbrain, accompanied by oculomotor nerve palsy or pupils that are dilated and non-reactive. Other supranuclear gaze abnormalities do not constitute exclusion criteria. 7. Irreversible impairment of brainstem function, characterized by bilateral fixed and dilated pupils, extensor motor posturing, and a Glasgow Coma Scale (GCS) score of ≤ 4. 8. Indications for craniotomy in patients include: 1) progressive impairment of consciousness; 2) presence of brain herniation, with signs related to cerebellar tonsil herniation or temporal lobe gyrus herniation; 3) hematoma located within 1 cm of the cortical surface. 9. CT evidence suggesting a high risk of rebleeding, such as spot sign. 10. Platelet count \<100,000/mL; INR \>1.4. 11. Any irreversible coagulation disorders (e.g., hemophilia, von Willebrand disease, use of anticoagulants such as warfarin) or known clotting disorders (e.g., hypercoagulable states). 12. Inability to maintain INR ≤1.4 using short-acting and long-acting procoagulants (e.g., recombinant human coagulation factor VIIa, fresh frozen plasma, vitamin K, etc.). 13. Subjects necessitating long-term anticoagulation therapy are excluded from participation. Reversal of anticoagulation is permissible for medically stable patients who can feasibly tolerate the short-term risks associated with reversal. Patients must not require Coumadin (warfarin) or other anticoagulants during the initial 30-day period. 14. Prior to the onset of symptoms, anticoagulants such as dabigatran, apixaban, or rivaroxaban, as well as treatments like tirofiban, ticagrelor, cilostazol, or clopidogrel, were used. 15. Internal bleeding involving the retroperitoneal, gastrointestinal, or genitourinary system, or respiratory tract bleeding. 16. Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures, etc.) or site of recent surgical intervention. 17. Positive urine or serum pregnancy test in pre-menopausal female subjects without a documented history of surgical sterilization. 18. Allergy/sensitivity to TNK. 19. Prior enrollment in the study. 20. Engagement in a concurrent interventional clinical investigation or trial. Patients enrolled in observational, natural history, or epidemiological studies that do not involve any form of intervention remain eligible. 21. Not expected to survive until the day 180 visit due to co-morbidities, or having DNR/DNI status (Do-Not-Resuscitate and Do-Not-Intubate) prior to randomization. 22. The presence of any concurrent serious illness that could confound outcome assessments, including but not limited to hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders. 23. Patients with mechanical heart valves are excluded. The presence of bioprosthetic valve(s) is permissible. 24. Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is permitted. 25. Any other condition that, in the investigator's judgment, would present a significant risk to the subject if the investigational therapy were to be initiated. 26. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. 27. Patients deemed by the investigator to have unstable conditions that may benefit from other treatments. 28. Patients requesting conservative treatment or standard craniotomy microsurgery treatment. 29. The subject or their legal guardian/representative demonstrates an inability or lack of willingness to provide written informed consent.
Contact & Investigator
Yong Cao
PRINCIPAL INVESTIGATOR
Beijing Tiantan Hospital
Frequently Asked Questions
Who can join the NCT06868511 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Deep Intracerebral Hemorrhage (ICH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06868511 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 732 participants.
Is NCT06868511 currently recruiting?
Yes, NCT06868511 is actively recruiting participants. Contact the research team at caoyong@bjtth.org for enrollment information.
Where is the NCT06868511 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06868511 clinical trial?
NCT06868511 is sponsored by Beijing Tiantan Hospital. The principal investigator is Yong Cao at Beijing Tiantan Hospital. The trial plans to enroll 732 participants.