NCT07208097

Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 768 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracerebral Haemorrhage
• Minimally Invasive Treatment

Interventions

Type	Name	Description
PROCEDURE	Stereotactic thrombolysis with Tenecteplase	Stereotactic thrombolysis with Tenecteplase for ICH is a minimally invasive method for evacuation hematoma. The hematoma puncture target is identified via CT imaging before surgery. After local anesthesia and sedation, stereotactic minimally invasive surgery is performed with the Leksell stereotactic frame. A postoperative CT scan is immediately conducted to confirm the absence of intracranial rebleeding before administering tenecteplase into the hematoma. Tenecteplase is fully diluted in 2 mL of saline and injected into the hematoma cavity via an irrigation catheter. The drainage tube is clamped for 1 hour before opening (early opening is permitted if necessary). The single dose of TNK is 0.5 mg and can be administered with a maximum of 2 dose in every 24 hours. The target hematoma clearance criteria is: residual hematoma volume ≤10 mL or ≤20% of the initial volume.

Timeline

• Start date: 2025-10-25
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2025-10-06
• Last updated: 2025-12-01

Locations

2 sites across 1 country: China