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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 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

PROCEDURE

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