Clinical trial Recruiting at 51 sites Interventional Ages 18 to 80

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.

More Intracerebral Haemorrhage trials

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment768 (estimated)
SponsorTongji Hospital
Academic / other
Locations51 sites (Anqing, Anhui and 50 other locations)
StatusRecruiting
StartedOctober 25, 2025
Main results expectedDecember 31, 2027
Study endsJune 30, 2028
Registry record updatedNovember 3, 2026
Trial IDNCT07208097 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

  • 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
  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.