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Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
Sponsor: Tongji Hospital
Summary
This is a 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 and catheter placement followed by hematoma liquefaction and drainage using tenecteplase, 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
2026-11-03
Healthy Volunteers
No
Interventions
Stereotactic thrombolysis with Tenecteplase
Stereotactic thrombolysis with Tenecteplase for ICH is a minimally invasive surgery for hematoma evacuation. The hematoma puncture target is identified via CT imaging before surgery. Stereotactic surgery can be performed using neuronavigation, robotic assistance, or a stereotactic frame. A postoperative CT scan is conducted to confirm the absence of intracranial rebleeding before tenecteplase administration. 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 a maximum of 2 doses may be administered every 24 hours, with a total of no more than 4 doses throughout the treatment course. The target hematoma clearance criteria is: residual hematoma volume ≤10 mL or ≤20% of the initial volume.
Locations (51)
Anqing Hospital Affiliated to China Pharmaceutical University
Anqing, Anhui, China
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
The First Affiliated Hospital ofAnhui Medical University
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Suzhou First People's Hospital
Suzhou, Anhui, China
Sixian People's Hospital, Suzhou, Anhui Province
Suzhou, Anhui, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Zhijin County Hospital of Traditional Chinese Medicine
Bijie, Guizhou, China
Guizhou Medical University Affiliated Hospital
Guiyang, Guizhou, China
Majiang County People's Hospital
Kaili, Guizhou, China
Panzhou People's Hospital
Panzhou, Guizhou, China
The First Hospital of Yongnian District
Handan, Hebei, China
The Fouth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Jixi Mining Group General Hospital
Jixi, Heilongjiang, China
Xun County People's Hospital
Hebi, Henan, China
Jiaozuo People's Hospital
Jiaozuo, Henan, China
Lingbao First People's Hospital
Lingbao, Henan, China
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Puyang Hospital of Traditional Chinese Medicine
Puyang, Henan, China
Sanmenxia Central Hospital (Encephalopathy Hospital)
Sanmenxia, Henan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
Zhengzhou Yangcheng Hospital
Zhengzhou, Henan, China
Suizhou Central Hospital
Suizhou, Hubei, China
Xianning Central Hospital
Xianning, Hubei, China
Liuyang Hospital of Traditional Chinese Medicine
Guankou, Hunan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Donghai County Hospital of Traditional Chinese Medicine
Lianyungang, Jiangsu, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
Siping Central People's Hospital
Siping, Jilin, China
Baoji Hospital of Traditional Chinese Medicine
Baoji, Shaanxi, China
Linyi People's Hospital
Linyi, Shandong, China
Linyi County People's Hospital
Dezhou, Shangdong, China
Gao County Hospital of Traditional Chinese Medicine
Yibin, Sichuan, China
Ningbo University Affiliated First Hospital
Ningbo, Zhejiang, China
Wenzhou Central Hospital
Wenzhou, Zhejiang, China
Beijing Electric Power Hospital
Beijing, China
Peking University International Hospital
Beijing, China
Three Gorges Hospital, Chongqing University
Chongqing, China
Enshi Tujia and Miao Autonomous Prefecture Central Hospital
Enshi, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
Shandong Provincial Third Hospital
Jinan, China
The First Affiliated Hospital of Henan University
Kaifeng, China
Danzhai County People's Hospital, Guizhou Province
Kaili, China
The First Hospital of Lanzhou University
Lanzhou, China
Laohekou First Hospital
Laohekou, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Nanyang Second People's Hospital
Nanyang, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
Yibin First People's Hospital
Yibin, China
Yichang Central People's Hospital
Yichang, China