Neuronavigation-assisted Stereotactic Minimally Invasive Puncture With Tenecteplase for Acute Lob… (NCT07471256) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Neuronavigation-assisted Stereotactic Minimally Invasive Puncture With Tenecteplase for Acute Lobar Intracerebral Hemorrhage
China636 participantsStarted 2026-03-31
Plain-language summary
Introduction: Minimally invasive puncture surgery with thrombolysis is effective for hypertensive intracerebral hemorrhage, but its effect on neurological recovery remains uncertain. The use of neuronavigation-assisted stereotactic technology can significantly improve the precision of catheter placement, while tenecteplase (TNK), a third-generation thrombolytic with high fibrin specificity and superior activity against platelet-rich clots. Nonetheless, the efficacy and safety of combining neuronavigation-assisted stereotactic minimally invasive puncture (NALCIE) with TNK for reducing disability and mortality in acute spontaneous lobar intracerebral hemorrhage have yet to be established.
Aim: To present the scientific rationale and study design of the neuronavigation-assisted stereotactic minimally invasive puncture combined with tenecteplase (NALICE-TNK) trial for the treatment of acute spontaneous lobar intracerebral hemorrhage.
Design: NALICE-TNK is a multicenter, randomized, open-label, assessor-blinded, clinical trial enrolling 636 patients with acute lobar intracerebral hemorrhage and hematoma volumes of 30-50 mL. The trial aims to assess the efficacy and safety of neuronavigation-assisted stereotactic minimally invasive puncture (MIPS) combined with tenecteplase (TNK), administered every 24 hours at a dose of 0.009 mg per mL of hematoma volume, versus standard medical care. All participants will undergo standardized 180-day follow-up.
Study outcomes: The primary efficacy endpoint is functional ambulation (a score of 0 to 3 on the modified Rankin scale; range, 0 to 6, with higher scores indicating more severe disability) at 180 days. The primary safety endpoint is all-cause mortality at 30 days.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years and \<80 years
. Symptoms must have manifested within 24 hours prior to the diagnostic CT (dCT) scan. Patients with indeterminate symptom onset are excluded; for those who awoke with symptoms, the last known well time is used.
. Acute spontaneous lobar intracerebral hemorrhage (ICH) occurring in the frontal lobe, parietal lobe, temporal lobe, or occipital lobe, with a volume between 30-50 mL, measured at the site using the ABC/2 method with radiographic imaging (CT, etc.).
. Glasgow Coma Scale (GCS) score of 5-14.
. Stability CT scan done at least 6 hours after diagnostic CT showing clot stability (growth\<5 mL as measured by ABC/2 method).
. Randomization should occur within 6 to 24 hours after the diagnostic CT.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants with mRS 0-3 at 180 days
. Systolic blood pressure (SBP) less than 180 mmHg maintained for a duration of six hours, documented proximate to the randomization time point.
. Historical modified Rankin (mRS) score of 0 or 1.
Exclusion criteria
. Hemorrhage in the basal ganglia, thalamus, or subtentorial region, including posterior fossa and cerebellar hemorrhage.
. Stability CT scan done at least 6 hours after diagnostic CT showing clot instability (growth ≥5 mL as measured by ABC/2 method).
. Intraventricular hemorrhage necessitating intervention to address mass effect or midline shift attributable to trapped ventricle syndrome secondary to intraventricular hemorrhage (IVH)-related casting.
. 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.
. Patients presenting with an unstable intracranial mass or progressive intracranial compartment syndrome.
. National Institutes of Health Stroke Scale (NIHSS) score ≤ 5.
. Presence of puncture contraindications.
. Irreversible impairment of brainstem function, characterized by bilateral fixed and dilated pupils, extensor motor posturing, and a Glasgow Coma Scale (GCS) score of ≤ 4.