RecruitingNot ApplicableNCT07208097

Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage

Sponsor

Tongji Hospital

Enrollment

768 participants

Start Date

Oct 25, 2025

Study Type

INTERVENTIONAL

Conditions

Intracerebral haemorrhage Minimally Invasive Treatment

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Stereotactic thrombolysis with Tenecteplase for people with intracerebral haemorrhage and minimally invasive treatment. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREStereotactic 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.