Actively Recruiting
Neuronavigation-assisted Stereotactic Puncture With Tenecteplase for Acute Intracerebral Hemorrhage
Led by Beijing Tiantan Hospital · Updated on 2025-04-22
732
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neuronavigation-assisted Stereotactic Puncture With Tenecteplase for Acute Intracerebral Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and under 80 years.
- Symptoms started within 24 hours before the diagnostic CT scan.
- Acute spontaneous deep intracerebral hemorrhage in basal ganglia or thalamus with hematoma volume 20-50 mL.
- Glasgow Coma Scale score between 5 and 14.
- Stability CT scan at least 6 hours after diagnostic CT showing clot growth less than 5 mL.
- Randomization within 6 to 24 hours after diagnostic CT.
- Systolic blood pressure less than 180 mmHg maintained for six hours near randomization.
- Historical Rankin score of 0 or 1.
You will not qualify if you...
- Lobar or subtentorial hemorrhage, including posterior fossa and cerebellar hemorrhage.
- Stability CT scan showing clot growth of 5 mL or more.
- Intraventricular hemorrhage needing intervention for mass effect or midline shift.
- Hemorrhage due to other cerebrovascular conditions like ruptured aneurysm or arteriovenous malformation.
- Unstable intracranial mass or progressive intracranial compartment syndrome.
- Thalamic hemorrhages extending into midbrain with oculomotor nerve palsy or fixed dilated pupils.
- Irreversible brainstem impairment with Glasgow Coma Scale score 4 or less.
- Indications for craniotomy such as progressive consciousness impairment or hematoma near cortical surface.
- CT signs of high rebleeding risk, like spot sign.
- Platelet count below 100,000/mL or INR above 1.4.
- Irreversible coagulation disorders or known clotting disorders.
- Inability to maintain INR below or equal to 1.4 using procoagulants.
- Need for long-term anticoagulation therapy.
- Use of anticoagulants or antiplatelet agents before symptom onset.
- Internal bleeding in retroperitoneal, gastrointestinal, genitourinary, or respiratory tracts.
- Superficial bleeding at vascular puncture or recent surgical sites.
- Positive pregnancy test in pre-menopausal females without surgical sterilization.
- Allergy or sensitivity to tenecteplase.
- Prior enrollment in this study.
- Participation in other interventional clinical trials.
- Not expected to survive to 180 days or having Do-Not-Resuscitate/Do-Not-Intubate status.
- Serious concurrent illnesses that could affect outcome assessments.
- Presence of mechanical heart valves.
- Known risk for embolization conditions.
- Any condition posing significant risk with the investigational therapy.
- Active drug or alcohol dependence interfering with study adherence.
- Unstable conditions needing other treatments.
- Requesting conservative or standard craniotomy microsurgery treatment.
- Inability or unwillingness to provide written informed consent.
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, China, China, 100000
Actively Recruiting
Research Team
Y
Yong Cao
CONTACT
Z
Zhiyou Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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