Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
- Conditions
- Intracerebral HaemorrhageMinimally Invasive Treatment
- Registration Number
- NCT07208097
- Lead Sponsor
- Tongji Hospital
- Brief Summary
This is an phase III prospective, multi-center, open-label, randomized controlled trial (RCT) with blinded endpoint assessment. It plans to enroll 768 subjects with spontaneous supratentorial intracerebral hemorrhage, who will be randomly assigned in a 1:1 ratio to the investigational arm (stereotactic minimally invasive puncture for intracerebral hemorrhage combined with TNK liquefaction drainage, single TNK dose of 0.5mg per time or the standard medical treatment group.
- Detailed Description
Intracerebral hemorrhage (ICH) is an acute cerebrovascular disease with an incidence rate of 60-80 cases per 100,000 population annually, accounting for approximately 10%-20% of all strokes. Early mortality in ICH patients can reach 30%-40%, and the disability rate remains high in later stages, with roughly two-thirds of patients ultimately dying or becoming disabled.
Brain injury caused by ICH can be categorized into primary and secondary damage. Primary injury results from direct trauma to white matter tracts, the blood-brain barrier, and hematoma mass effect immediately following bleeding. Secondary injury arises from mechanisms such as inflammation, blood-brain barrier disruption, cerebral edema, perihematomal edema, cytotoxicity, and oxidative stress, leading to neurological deficits. Clinical studies have confirmed that hematoma removal reduces mortality in ICH patients and may improve neurological outcomes. Minimally invasive hematoma evacuation combined with thrombolytics like rt-PA or urokinase has shown safety and reduced mortality but fails to improve functional outcomes. Post-hoc analyses reveal variable efficacy of rt-PA in liquefying hematomas, with incomplete evacuation and residual clots in some patients. Theoretically, faster and more efficient hematoma liquefaction could enhance clinical outcomes. Tenecteplase has demonstrated superior efficacy, rapid action, and safety in ischemic stroke compared to rt-PA, suggesting potential benefits for ICH hematoma clearance.
To determine the efficacy and safety of local injection of TNK via stereotactic minimally invasive puncture surgery for the treatment of acute spontaneous supratentorial intracerebral hemorrhage (ICH). This is a national, multicenter clinical trial spontaneously organized and designed by the investigators. It employs a Phase III prospective, multicenter, open-label, randomized, standard medical therapy parallel-controlled design, with blinded endpoint assessors. Subjects meeting the inclusion and exclusion criteria will be enrolled according to randomization principles. Investigators blinded to group allocation will conduct assessments and evaluations at various time points during the follow-up period for enrolled patients' post-randomization, either through face-to-face visits or telephone follow-ups.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 768
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Functional Improvement (good functional outcome: mRS 0-3) 180 days post-randomization The primary outcome is the proportion of patients with a favorable functional outcome (mRS score 0-3) at 180 days post-randomization.
- Secondary Outcome Measures
Name Time Method Functional Improvement (Ordinal analysis of mRS) 180 days post-randomization Ordinal analysis of mRS scores at 180 days post-randomization
Functional Improvement (uw-mRS) 180 days post-randomization Functional Improvement as determined by utility-weighted modified Rankin Scale (uw-mRS) which is assigned to seven levels: 1.0, 0.91, 0.76, 0.65, 0.33, 0.0, and 0.0 (with higher scores indicating a better outcome, according to patients' assessment)
Functional Improvement (good functional outcome mRS 0-2) 180 days post-randomization Proportion of subjects with mRS score 0-2 at 180 days post-randomization
Functional Improvement (good functional outcome mRS 0-1) 180 days post-randomization Proportion of subjects with mRS score 0-1 at 180 days post-randomization
Functional Improvement (good functional outcome: eGOS 4-8) 180 days post-randomization eGOS score at 180 days post-randomization (favorable: 4-8; unfavorable: 1-3)
Health-related quality of daily life 180 days post-randomization EQ-5D-5L score at 180 days post-randomization
Mortality 180 days post-randomization All-cause mortality at 180 days post-randomization
Early neurological improvement Day 7 (or at early discharge if earlier) Change in NIHSS score from baseline to Day 7 (or at early discharge if earlier)
Residual hematoma volume Day 7 post-randomization Residual hematoma volume on Day 7 post-randomization
Clot removal rate 7 days post-randomization Hematoma clearance rate at 7 days post-randomization
Length of hospital stay and economic from symptom onset to 180 days post-randomization ICU length of stay (from symptom onset to end of follow-up)