Stereotactic tenecteplase clot liquefaction for supratentorial intracerebral hemorrhage
Official title: Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
Run by Tongji Hospital · NCT07208097 · Data updated 2026-11-12
This trial will see if stereotactic minimally invasive clot drainage plus a single low dose of tenecteplase helps adults with moderate-to-large supratentorial intracerebral hemorrhage recover better than standard medical care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 768 (estimated) |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 51 sites (Anqing, Anhui and 50 other locations) |
| Status | Recruiting |
| Started | October 25, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07208097 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–80 years old with spontaneous supratentorial ICH presenting within 24 hours, hematoma volume 25–60 mL, NIHSS ≥6, GCS 9–14, and pre-stroke mRS ≤1 who can consent and attend follow-up.
✕Probably not a fit
Patients with brainstem or cerebellar hemorrhages, very small or very large hematomas outside the 25–60 mL range, severe coma, contraindications to thrombolytics or invasive procedures, or late presentation (>24 hours) are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase III, prospective, multicenter, open-label randomized controlled trial with blinded endpoint assessment will enroll 768 adults with spontaneous supratentorial intracerebral hemorrhage and randomize them 1:1 to stereotactic minimally invasive puncture plus tenecteplase liquefaction drainage (single 0.5 mg TNK dose) or to standard medical management. Eligible patients must present within 24 hours of symptom onset with hematoma volumes of 25–60 mL, NIHSS ≥6, GCS 9–14, and pre-stroke mRS ≤1. The intervention aims to speed hematoma liquefaction and drainage to reduce secondary brain injury and improve outcomes. Clinical outcomes will be adjudicated by blinded assessors to limit bias.
Why it matters
Potential benefit: If successful, the approach could speed clot removal, lower early mortality, and improve functional recovery after intracerebral hemorrhage.
How similar studies have gone: Minimally invasive evacuation combined with rt‑PA or urokinase has shown safety and reduced mortality but not consistent functional improvement, and tenecteplase is promising in ischemic stroke but largely untested for ICH in large randomized trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria : 1. . Age 18 to 80 years, any gender. 2. . Clinically confirmed acute spontaneous supratentorial intracerebral hemorrhage (ICH), with diagnostic CT completed within 24 hours of symptom onset (for patients with unknown time of onset or wake-up stroke, the time from the last known well to symptom detection is used as the presumed onset time). 3. . CT-confirmed supratentorial ICH with hematoma volume calculated by ABC/2 method between 25 mL and 60 mL (inclusive). 4. . National Institutes of Health Stroke Scale (NIHSS) score ≥ 6. 5. .Glasgow Coma Scale (GCS) score between 9 and 14 (inclusive). 6. . Pre-stroke modified Rankin Scale (mRS) score ≤ 1. 7. . Good compliance, with written informed consent provided by the patient and/or legal guardian, and ability to adhere to the scheduled follow-up visits. Exclusion Criteria: 1. . Brainstem or cerebellar hemorrhage; or thalamic hemorrhage with significant midbrain shift accompanied by third nerve palsy or unreactive dilated pupils. 2. . Irreversible brainstem dysfunction (bilateral fixed, dilated pupils and decerebrate posturing). 3. . Secondary ICH caused by: head trauma, arteriovenous malformation (AVM), moyamoya disease, intracranial aneurysm, coagulation disorders (hereditary or acquired hemorrhagic diathesis, hemophilia, coagulation factor deficiency, leukemia, etc.), hemorrhagic transformation of cerebral infarction, or tumor; multiple intracranial hemorrhages, subarachnoid hemorrhage (SAH), primary intraventricular hemorrhage, drug-induced hemorrhagic stroke, subdural hemorrhage, epidural hemorrhage. 4. . Significant abnormalities in the following laboratory parameters:(1)International normalized ratio (INR) \> 1.4; any irreversible coagulopathy or known coagulation disorder that cannot be corrected with procoagulants to maintain INR ≤ 1.4. (2) Severe hepatic insufficiency: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 times the upper limit of normal (ULN). (3) Severe renal insufficiency: estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m². (4)Hemoglobin \< 90 g/L.5)Platelet count \< 100 × 10⁹/L. 5. . History of malignancy, autoimmune diseases (including but not limited to systemic lupus erythematosus, systemic vasculitis), hemorrhagic diathesis (including various hereditary and acquired bleeding disorders), malignant arrhythmias, cardiac insufficiency (B-type natriuretic peptide \[BNP\] ≥ 1000 pg/mL or left ventricular ejection fraction \[LVEF\] ≤ 40%), acute myocardial infarction, acute or severe infectious diseases (e.g., intracranial infection, severe pneumonia, sepsis), or any other severe concurrent illness that may exacerbate the condition or interfere with efficacy assessment. 6. . Known high risk of thromboembolism, including: presence of a mechanical heart valve prosthesis, history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. (Note: Atrial fibrillation without mitral stenosis is permitted). 7. . Myocardial infarction within 30 days prior to randomization. 8. .Use of anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban) within 1 week prior to symptom onset. 9. . History of internal bleeding (e.g., gastrointestinal bleeding, genitourinary bleeding, retroperitoneal bleeding) within 3 months prior to randomization. 10. . Major surgery or vascular puncture (e.g., venesection, arterial puncture) within 3 months prior to randomization. 11. . History of significant head trauma or severe stroke within 3 months prior to randomization. 12. . History of intracerebral hemorrhage within 1 year prior to randomization. 13. . Indications for craniotomy: (1) Progressive impairment of consciousness; (2)Preoperative signs of brain herniation (e.g., foramen magnum herniation, tentorial herniation) posing a life-threatening condition. 14. . Intraventricular hemorrhage (IVH) or ICH with rupture into the ventricle causing intraventricular cast formation and/or hydrocephalus anticipated to require external ventricular drainage (EVD). 15. . Patient or family requests craniotomy or neuroendoscopic surgery for hematoma evacuation. 16. . Pre-randomization decision by patient/family for Do-Not-Resuscitate (DNR) or Do-Not-Intubate (DNI) orders regarding life-sustaining measures. 17. . Known hypersensitivity or intolerance to TNK. 18. . Pregnancy (positive urine pregnancy test) in women of childbearing potential. 19. . Concurrent participation in another investigational drug or device study. 20. . History of drug or alcohol abuse/dependence, severe dementia, or psychiatric disorder prior to randomization, anticipated to result in poor compliance and inability to complete follow-up.
Where it's running
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Anqing Hospital Affiliated to China Pharmaceutical University
Anqing, Anhui, China Recruiting -
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China Recruiting -
The First Affiliated Hospital ofAnhui Medical University
Hefei, Anhui, China Recruiting -
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China Recruiting -
Suzhou First People's Hospital
Suzhou, Anhui, China Recruiting -
Sixian People's Hospital, Suzhou, Anhui Province
Suzhou, Anhui, China Recruiting
Show 44 more locations
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Guangzhou First People's Hospital
Guangzhou, Guangdong, China Recruiting -
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China Recruiting -
Zhijin County Hospital of Traditional Chinese Medicine
Bijie, Guizhou, China Recruiting -
Guizhou Medical University Affiliated Hospital
Guiyang, Guizhou, China Recruiting -
Majiang County People's Hospital
Kaili, Guizhou, China Recruiting -
Panzhou People's Hospital
Panzhou, Guizhou, China Recruiting -
The First Hospital of Yongnian District
Handan, Hebei, China Recruiting -
The Fouth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China Recruiting -
Jixi Mining Group General Hospital
Jixi, Heilongjiang, China Recruiting -
Xun County People's Hospital
Hebi, Henan, China Recruiting -
Jiaozuo People's Hospital
Jiaozuo, Henan, China Recruiting -
Lingbao First People's Hospital
Lingbao, Henan, China Recruiting -
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China Recruiting -
Puyang Hospital of Traditional Chinese Medicine
Puyang, Henan, China Recruiting -
Sanmenxia Central Hospital (Encephalopathy Hospital)
Sanmenxia, Henan, China Recruiting -
Zhengzhou Central Hospital
Zhengzhou, Henan, China Recruiting -
Zhengzhou Yangcheng Hospital
Zhengzhou, Henan, China Recruiting -
Suizhou Central Hospital
Suizhou, Hubei, China Recruiting -
Xianning Central Hospital
Xianning, Hubei, China Recruiting -
Liuyang Hospital of Traditional Chinese Medicine
Guankou, Hunan, China Recruiting -
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China Recruiting -
Donghai County Hospital of Traditional Chinese Medicine
Lianyungang, Jiangsu, China Recruiting -
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China Recruiting -
Siping Central People's Hospital
Siping, Jilin, China Recruiting -
Baoji Hospital of Traditional Chinese Medicine
Baoji, Shaanxi, China Recruiting -
Linyi People's Hospital
Linyi, Shandong, China Recruiting -
Linyi County People's Hospital
Dezhou, Shangdong, China Recruiting -
Gao County Hospital of Traditional Chinese Medicine
Yibin, Sichuan, China Recruiting -
Ningbo University Affiliated First Hospital
Ningbo, Zhejiang, China Recruiting -
Wenzhou Central Hospital
Wenzhou, Zhejiang, China Recruiting -
Beijing Electric Power Hospital
Beijing, China Recruiting -
Peking University International Hospital
Beijing, China Recruiting -
Three Gorges Hospital, Chongqing University
Chongqing, China Recruiting -
Enshi Tujia and Miao Autonomous Prefecture Central Hospital
Enshi, China Recruiting -
The Second Affiliated Hospital of Harbin Medical University
Harbin, China Recruiting -
Shandong Provincial Third Hospital
Jinan, China Recruiting -
The First Affiliated Hospital of Henan University
Kaifeng, China Recruiting -
Danzhai County People's Hospital, Guizhou Province
Kaili, China Recruiting -
The First Hospital of Lanzhou University
Lanzhou, China Recruiting -
Laohekou First Hospital
Laohekou, China Recruiting -
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China Recruiting -
Nanyang Second People's Hospital
Nanyang, China Recruiting -
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China Recruiting -
Yibin First People's Hospital
Yibin, China Recruiting
+1 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Pan Chao, MD, PhD
- Email: ddjtzp@163.com; punctualpc@163.com
- Phone: 86-027-83663337
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.