Neuronavigation-assisted Stereotactic Minimally Invasive Puncture With Tenecteplase for Acute Lobar Intracerebral Hemorrhage

NCT07471256 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: NALICE-TNK-ICH
• Study Type: interventional
• Target: 636
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracerebral Hemorrhage Lobar

Keywords

Neuronavigation-assisted Stereotactic; Lobar intracerebral hemorrhage; Minimally invasive puncture; Tenecteplase (TNK); Multicenter randomized trial; Hematoma evacuation

Outcome Measures

Primary Outcomes (2)

• Proportion of participants with mRS 0-3 at 180 days

  The primary outcome is the proportion of participants with a modified Rankin Scale (mRS) score of 0-3 (range, 0 to 6, with higher scores indicating more severe disability) at 180 days.

  180 ±14 days

• All-cause death at 30 days post-randomization

  All-cause death at 30 days post-randomization

  30-day post-randomization period

Secondary Outcomes (16)

• Functional independence of patients with adjudicated mRS of 0-2 at 180 days post-randomization.

  180 ± 14 days

• Excellent functional outcome of patients with adjudicated mRS of 0-1 at 180 days post-randomization.

  180 ±14 days

• Distribution of mRS scores (0-6) at 180 days post-randomization.

  180 ± 14 days

• Distribution of mRS scores (0-6) at 30 days post-randomization

  30 days post-randomization

• Residual hematoma volume at 24 hours post the final administration.

  24 hours after the last administration of TNK

Study Arms (2)

Standard medical treatment group

SHAM COMPARATOR

The standard medical treatment for this group of patients will be provided according to the optimal care standards outlined by the American Heart Association (AHA) for the management of intracerebral hemorrhage.

Drug: Standard medical treatment

NALICE-TNK group

EXPERIMENTAL

This intervention involves neuronavigation-assisted stereotactic minimally invasive puncture for acute spontaneous lobar intracerebral hemorrhage (NALICE) combined with tenecteplase (TNK) . NALICE enhances catheter placement precision, reducing complications and improving hematoma evacuation and neurological outcomes. TNK, a third-generation thrombolytic, offers advantages over alteplase (rt-PA) , including a longer half-life for rapid bolus administration and effective thrombolytic effects to dissolve clots and promote hematoma clearance.

Procedure: Neuronavigation-assisted Stereotactic Minimally Invasive Puncture Combined with Tenecteplase

Interventions

Neuronavigation-assisted Stereotactic Minimally Invasive Puncture Combined with Tenecteplase PROCEDURE

Neuronavigation-assisted stereotactic minimally invasive puncture will enhances catheter placement precision, reducing complications and improving hematoma evacuation and neurological outcomes. TNK, a third-generation thrombolytic will offers advantages over alteplase (rt-PA), including a longer half-life for rapid bolus administration and effective thrombolytic effects to dissolve clots and promote hematoma clearance.

NALICE-TNK group

Standard medical treatment DRUG

The standard medical treatment for this group of patients will be provided according to the optimal care standards defined by the American Heart Association (AHA) guidelines for intracerebral hemorrhage management

Standard medical treatment group

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 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.
• 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.

You may not qualify if:

• 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.
• 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 herniatio.
• CT evidence suggesting a high risk of rebleeding, such as spot sign.
• Platelet count \<100,000/mL; INR \>1.4.
• Any irreversible coagulation disorders (e.g., hemophilia, von Willebrand disease, use of anticoagulants such as warfarin) or known clotting disorders (e.g., hypercoagulable states).
• 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.).
• 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 8-week period.
• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Beijing, China 100000

Beijing, China

Location

MeSH Terms

Interventions

Tenecteplase

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Yong Cao

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Cao

CONTACT

+86 13601362306; caoyong@bjtth.org

Jinyi Tang

CONTACT

+8613219378078; strive0225@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (1)