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RECRUITING
NCT07208097
NA

Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

768

Start Date

2025-10-25

Completion Date

2028-06-30

Last Updated

2025-12-01

Healthy Volunteers

No

Interventions

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.

Locations (2)

Suzhou First People's Hospital

Suzhou, Anhui, China

Guizhou Medical University Affiliated Hospital

Guiyang, Guizhou, China