Intracerebral HaemorrhageSTEPSNCT07208097
Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
A study testing Stereotactic thrombolysis with Tenecteplase in people with Intracerebral Haemorrhage and Minimally Invasive Treatment, run by Tongji Hospital at 51 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Haemorrhage, Minimally Invasive Treatment
- What is being tested?
- Stereotactic thrombolysis with Tenecteplase
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 768 participants
- Where
- 51 sitesChina
- Study dates
- 25 Oct 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . Age 18 to 80 years, any gender.
- . 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).
- . CT-confirmed supratentorial ICH with hematoma volume calculated by ABC/2 method between 25 mL and 60 mL (inclusive).
- . National Institutes of Health Stroke Scale (NIHSS) score ≥ 6.
- .Glasgow Coma Scale (GCS) score between 9 and 14 (inclusive).
- . Pre-stroke modified Rankin Scale (mRS) score ≤ 1.
- . Good compliance, with written informed consent provided by the patient and/or legal guardian, and ability to adhere to the scheduled follow-up visits.
Who cannot join
- . Brainstem or cerebellar hemorrhage; or thalamic hemorrhage with significant midbrain shift accompanied by third nerve palsy or unreactive dilated pupils.
- . Irreversible brainstem dysfunction (bilateral fixed, dilated pupils and decerebrate posturing).
- . 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.
- . 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.
- . 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.
- . 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).
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- . Myocardial infarction within 30 days prior to randomization.
- .Use of anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban) within 1 week prior to symptom onset.
- . History of internal bleeding (e.g., gastrointestinal bleeding, genitourinary bleeding, retroperitoneal bleeding) within 3 months prior to randomization.
- . Major surgery or vascular puncture (e.g., venesection, arterial puncture) within 3 months prior to randomization.
- . History of significant head trauma or severe stroke within 3 months prior to randomization.
- . History of intracerebral hemorrhage within 1 year prior to randomization.
- . 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.
- . Intraventricular hemorrhage (IVH) or ICH with rupture into the ventricle causing intraventricular cast formation and/or hydrocephalus anticipated to require external ventricular drainage (EVD).
- . Patient or family requests craniotomy or neuroendoscopic surgery for hematoma evacuation.
- . Pre-randomization decision by patient/family for Do-Not-Resuscitate (DNR) or Do-Not-Intubate (DNI) orders regarding life-sustaining measures.
- . Known hypersensitivity or intolerance to TNK.
- . Pregnancy (positive urine pregnancy test) in women of childbearing potential.
- . Concurrent participation in another investigational drug or device study.
- . 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.
Trial locations and contacts
51 sites in 1 country. Contact the study team or a site near you to ask about taking part.
51 sites in 1 country
China51 sites, 51 recruiting
- Recruiting
Anqing Hospital Affiliated to China Pharmaceutical University
Anqing, Anhui
Zha Zhengjiang, 86+13855665656, Chazj@126.com
- Recruiting
Baoji Hospital of Traditional Chinese Medicine
Baoji, Shaanxi
Wang Xiaofeng, 86+13609275317, wxf1.0@163.com
- Recruiting
Beijing Electric Power Hospital
Beijing
Zong Miao, 86+18911212112, zongmiao_bj@163.com
- Recruiting
Peking University International Hospital
Beijing
Lu Changyu, 86+15501063389, luchangyu@pkuih.edu.cn
- Recruiting
Zhijin County Hospital of Traditional Chinese Medicine
Bijie, Guizhou
Liu Yalin, 86+15761639541, 2212760678@qq.com
- Recruiting
China-Japan Union Hospital of Jilin University
Changchun, Jilin
Zhang Jinnan, 86+18686690066, jnzhang@jlu.edu.cn
- Recruiting
Three Gorges Hospital, Chongqing University
Chongqing
Wang Jing, 86+18523054852, 13834676852@163.com
- Recruiting
Linyi County People's Hospital
Dezhou, Shangdong
Niu Siqiang, 86+18678351862, nsq1234@163.com
- Recruiting
Enshi Tujia and Miao Autonomous Prefecture Central Hospital
Enshi
Tian Renfu, 86+13986843984, 2863687530@qq.com
- Recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong
Luo Jinbiao, 86+13903008636, ljbdoc@126.com
- Recruiting
Liuyang Hospital of Traditional Chinese Medicine
Guankou, Hunan
Bian Zhongmin, 86+15116263589, bianzhongmin438@sohu.com
- Recruiting
Guizhou Medical University Affiliated Hospital
Guiyang, Guizhou, 550000
Wang Likun, 86+13885084727, likunwang@163.com
- Recruiting
The First Hospital of Yongnian District
Handan, Hebei
Yan Gulei, 86+18131021898, 171433692@qq.com
- Recruiting
The Fouth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Wang Xuefeng, 86+15846500566, wxf1973@139.com
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin
Wang Jianjiao, 86+13895754712, wangjianjiao@163.com
- Recruiting
Xun County People's Hospital
Hebi, Henan
Li Jiahui, 86+15839292788, lijiahuihb@163.com
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
Xu Hao, 86+18019576586, Xuhao2021@ustc.edu.cn
- Recruiting
The First Affiliated Hospital ofAnhui Medical University
Hefei, Anhui
Wang Yi, 86+15056000767, wangyi.nsg@foxmail.com
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Li Qi, 86+18523381983, qili_md@126.com
- Recruiting
The First Affiliated Hospital of University of South China
Hengyang, Hunan
Qu Hongtao, 86+18216018797, qht959801@sina.com
- Recruiting
Jiaozuo People's Hospital
Jiaozuo, Henan
Wang Yangang, 86+18639916722, yszakffh@163.com
- Recruiting
Shandong Provincial Third Hospital
Jinan
Wang Tingzhong, 86+18900912311, wangtingzhong@126.com
- Recruiting
Jixi Mining Group General Hospital
Jixi, Heilongjiang
Liu Qiang, 86+13763673363, 85511248@qq.com
- Recruiting
The First Affiliated Hospital of Henan University
Kaifeng
Ma Jiangong, 86+13707611604, 13707611604@163.com
- Recruiting
Majiang County People's Hospital
Kaili, Guizhou
Yang Yuankang, 86+18685454424, 392230485@qq.com
- Recruiting
Danzhai County People's Hospital, Guizhou Province
Kaili
Long Wenkai, 86+18285569010, 1419185303@qq.com
- Recruiting
The First Hospital of Lanzhou University
Lanzhou
Zheng Maohua, 86+13919070077, 2002maohua@163.com
- Recruiting
Laohekou First Hospital
Laohekou
Yang Hongqing, 86+15871046830, 15871046830@qq.com
- Recruiting
Donghai County Hospital of Traditional Chinese Medicine
Lianyungang, Jiangsu
86+13912181181, 876422895@qq.com
- Recruiting
Lingbao First People's Hospital
Lingbao, Henan
Li Wenming, 86+13939889969, k452865128@163.com
- Recruiting
Linyi People's Hospital
Linyi, Shandong
Xie Zhongxiang, 86+15264926263, xiezhongxiang8607@163.com
- Recruiting
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Xu Wenzhong, 86+13939943567, xwz2008181@163.com
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang
Li Tao, 86+13937914836, taoli@haust.edu.cn
- Recruiting
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Wu Jingzhan, 86+18577155332, jingzhanwumind@163.com
- Recruiting
Nanyang Second People's Hospital
Nanyang
Chen Yang, 86+18203862170, cycy1116@126.com
- Recruiting
Ningbo University Affiliated First Hospital
Ningbo, Zhejiang, 315010
Wang Zhepei, 86+13777069890, fagoce@126.com
- Recruiting
Panzhou People's Hospital
Panzhou, Guizhou
Liu Xinquan, 86+18845945511, 18845945511@163.com
- Recruiting
Puyang Hospital of Traditional Chinese Medicine
Puyang, Henan
Nie Xingyu, 86+15893289828, nxy369@126.com
- Recruiting
Sanmenxia Central Hospital (Encephalopathy Hospital)
Sanmenxia, Henan
Fang Dandong, 18937942989, ddfangxy@163.com
- Recruiting
Siping Central People's Hospital
Siping, Jilin
Li Xiaodong, 86+13843436488, lxd19760115@126.com
- Recruiting
Suizhou Central Hospital
Suizhou, Hubei
Cheng Wei, 86+15897606447, 68719857@qq.com
- Recruiting
Suzhou First People's Hospital
Suzhou, Anhui, 234000
Liu Bin, +8615255701930, 2217043918@qq.com
- Recruiting
Sixian People's Hospital, Suzhou, Anhui Province
Suzhou, Anhui
Wang Side, 86+18225961803, 981883328@qq.com
- Recruiting
Wenzhou Central Hospital
Wenzhou, Zhejiang
Lin Qun, 86+13757718194, 87960039@qq.com
- Recruiting
Xianning Central Hospital
Xianning, Hubei
Pang Yaxun, 86+15566837120, 571922564@qq.com
- Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang
Zhou Xiang, 86+18937337250, 44906700@qq.com
- Recruiting
Gao County Hospital of Traditional Chinese Medicine
Yibin, Sichuan
He Jie, 86+13808298820, 350728933@qq.com
- Recruiting
Yibin First People's Hospital
Yibin
Yang Shiqiang, 86+18383165792, Xiaoyangshiqiang@163.com
- Recruiting
Yichang Central People's Hospital
Yichang
Xia Kailai, 86+13972602099, 14763607@qq.com
- Recruiting
Zhengzhou Central Hospital
Zhengzhou, Henan
Liang Aming, 86+15038058293, liangaming1986@126.com
- Recruiting
Zhengzhou Yangcheng Hospital
Zhengzhou, Henan
Ma Xuhui, 86+15617717786, 459076192@qq.com
About this study
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.
Read the detailed description
Intracerebral hemorrhage (ICH) is an acute cerebrovascular disease with an incidence rate of 60-80 cases per 100,000 population annually, accounting for approximately 10%-20% of all strokes. Early mortality in ICH patients can reach 30%-40%, and the disability rate remains high in later stages, with roughly two-thirds of patients ultimately dying or becoming disabled.
Brain injury caused by ICH can be categorized into primary and secondary damage. Primary injury results from direct trauma to white matter tracts, the blood-brain barrier, and hematoma mass effect immediately following bleeding. Secondary injury arises from mechanisms such as inflammation, blood-brain barrier disruption, cerebral edema, perihematomal edema, cytotoxicity, and oxidative stress, leading to neurological deficits. Clinical studies have confirmed that hematoma removal reduces mortality in ICH patients and may improve neurological outcomes. Minimally invasive hematoma evacuation combined with thrombolytics like rt-PA or urokinase has shown safety and reduced mortality but fails to improve functional outcomes. Post-hoc analyses reveal variable efficacy of rt-PA in liquefying hematomas, with incomplete evacuation and residual clots in some patients. Theoretically, faster and more efficient hematoma liquefaction could enhance clinical outcomes. Tenecteplase has demonstrated superior efficacy, rapid action, and safety in ischemic stroke compared to rt-PA, suggesting potential benefits for ICH hematoma clearance.
To determine the efficacy and safety of local injection of TNK via stereotactic minimally invasive puncture surgery and catheter placement for the treatment of acute spontaneous supratentorial intracerebral hemorrhage (ICH). This is a national, multicenter clinical trial spontaneously organized and designed by the investigators. It employs a prospective, multicenter, open-label, randomized, standard medical therapy parallel-controlled design, with blinded endpoint assessors. Subjects meeting the inclusion and exclusion criteria will be enrolled according to randomization principles. Investigators blinded to group allocation will conduct assessments and evaluations at various time points during the follow-up period for enrolled patients' post-randomization, either through face-to-face visits, video or telephone follow-ups.
- Being tested
- Stereotactic thrombolysis with Tenecteplase
- Keywords
- intracerebral haemorrhage, minimally invasive treatment, hematoma evacuation, tenecteplase
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic thrombolysis with TenecteplaseProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| MIS+TNK | Experimental | In this group, patients receive standard medical treatment plus mininally invasive stereotactic catheter placement followed by hematoma liquefaction and drainage using tenecteplase (TNK). The single dose of tenecteplase is 0.5mg. Receives: Procedure: Stereotactic thrombolysis with Tenecteplase |
| Standard medical treatment | No intervention | Patients randomized to the control group will receive standard medical management according to the 2022 AHA/ASA Guideline for the Management of Spontaneous Intracerebral Hemorrhage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 3
The primary outcome is the proportion of patients with a functional outcome (mRS score 0-3) at 180 days post-randomization.
Measured: 180 days post-randomization
Secondary outcomes (10)
Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)
Ordinal analysis of mRS scores at 180 days post-randomization
Measured: 180 days post-randomization
Functional Outcomes Measured Via Utility Weighted Modified Rankin Score (mRS)
Functional Improvement as determined by utility-weighted modified Rankin Scale (uw-mRS) which is assigned to seven levels: 1.0, 0.91, 0.76, 0.65, 0.33, 0.0, and 0.0 (with higher scores indicating a better outcome, according to patients' assessment)
Measured: 180 days post-randomization
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 2
Proportion of subjects with mRS score 0-2 at 180 days post-randomization
Measured: 180 days post-randomization
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 1
Proportion of subjects with mRS score 0-1 at 180 days post-randomization
Measured: 180 days post-randomization
Functional Outcomes Measured Via eGOS of 4-8
eGOS score at 180 days post-randomization (favorable: 4-8; unfavorable: 1-3)
Measured: 180 days post-randomization
Mortality
All-cause mortality at 180 days post-randomization
Measured: 180 days post-randomization
Health-related quality of daily life
EQ-5D-5L score at 180 days post-randomization
Measured: 180 days post-randomization
Early neurological improvement
Change in NIHSS score from baseline to Day 7 (or at early discharge if earlier)
Measured: Day 7 (or at early discharge if earlier)
Residual hematoma volume
Residual hematoma volume on Day 7 post-randomization
Measured: Day 7 post-randomization
Clot removal rate
Hematoma clearance rate at 7 days post-randomization
Measured: 7 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start25 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HaemorrhageStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 768 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tang Zhouping, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208097
- Sponsor's protocol ID
- TJ IRB202608029
- Acronym
- STEPS
- Status last verified
- Nov 2026
- First submitted
- 8 Apr 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT07208097
- Acronym / sponsor ID
- STEPS / TJ IRB202608029
- Keywords
- intracerebral haemorrhage, minimally invasive treatment, hematoma evacuation, tenecteplase
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 768 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intracerebral hemorrhage (ICH) is an acute cerebrovascular disease with an incidence rate of 60-80 cases per 100,000 population annually, accounting for approximately 10%-20% of all strokes. Early mortality in ICH patients can reach 30%-40%, and the disability rate remains high in later stages, with roughly two-thirds of patients ultimately dying or becoming disabled.
Brain injury caused by ICH can be categorized into primary and secondary damage. Primary injury results from direct trauma to white matter tracts, the blood-brain barrier, and hematoma mass effect immediately following bleeding. Secondary injury arises from mechanisms such as inflammation, blood-brain barrier disruption, cerebral edema, perihematomal edema, cytotoxicity, and oxidative stress, leading to neurological deficits. Clinical studies have confirmed that hematoma removal reduces mortality in ICH patients and may improve neurological outcomes. Minimally invasive hematoma evacuation combined with thrombolytics like rt-PA or urokinase has shown safety and reduced mortality but fails to improve functional outcomes. Post-hoc analyses reveal variable efficacy of rt-PA in liquefying hematomas, with incomplete evacuation and residual clots in some patients. Theoretically, faster and more efficient hematoma liquefaction could enhance clinical outcomes. Tenecteplase has demonstrated superior efficacy, rapid action, and safety in ischemic stroke compared to rt-PA, suggesting potential benefits for ICH hematoma clearance.
To determine the efficacy and safety of local injection of TNK via stereotactic minimally invasive puncture surgery and catheter placement for the treatment of acute spontaneous supratentorial intracerebral hemorrhage (ICH). This is a national, multicenter clinical trial spontaneously organized and designed by the investigators. It employs a prospective, multicenter, open-label, randomized, standard medical therapy parallel-controlled design, with blinded endpoint assessors. Subjects meeting the inclusion and exclusion criteria will be enrolled according to randomization principles. Investigators blinded to group allocation will conduct assessments and evaluations at various time points during the follow-up period for enrolled patients' post-randomization, either through face-to-face visits, video or telephone follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIS+TNK | Experimental | Procedure: Stereotactic thrombolysis with TenecteplaseIn this group, patients receive standard medical treatment plus mininally invasive stereotactic catheter placement followed by hematoma liquefaction and drainage using tenecteplase (TNK). The single dose of tenecteplase is 0.5mg. |
| Standard medical treatment | No intervention | –Patients randomized to the control group will receive standard medical management according to the 2022 AHA/ASA Guideline for the Management of Spontaneous Intracerebral Hemorrhage. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- . Age 18 to 80 years, any gender.
- . 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).
- . CT-confirmed supratentorial ICH with hematoma volume calculated by ABC/2 method between 25 mL and 60 mL (inclusive).
- . National Institutes of Health Stroke Scale (NIHSS) score ≥ 6.
- .Glasgow Coma Scale (GCS) score between 9 and 14 (inclusive).
Key exclusion criteria (20 listed)
- . Brainstem or cerebellar hemorrhage; or thalamic hemorrhage with significant midbrain shift accompanied by third nerve palsy or unreactive dilated pupils.
- . Irreversible brainstem dysfunction (bilateral fixed, dilated pupils and decerebrate posturing).
- . 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.
- . 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.
- . 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic thrombolysis with TenecteplaseStereotactic 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. | Procedure or surgery | MIS+TNK |
Primary outcome
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 3
Time frame: 180 days post-randomization
The primary outcome is the proportion of patients with a functional outcome (mRS score 0-3) at 180 days post-randomization.
10 secondary outcomes
Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)
Time frame: 180 days post-randomization
Functional Outcomes Measured Via Utility Weighted Modified Rankin Score (mRS)
Time frame: 180 days post-randomization
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 2
Time frame: 180 days post-randomization
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 1
Time frame: 180 days post-randomization
Functional Outcomes Measured Via eGOS of 4-8
Time frame: 180 days post-randomization
Mortality
Time frame: 180 days post-randomization
Health-related quality of daily life
Time frame: 180 days post-randomization
Early neurological improvement
Time frame: Day 7 (or at early discharge if earlier)
Residual hematoma volume
Time frame: Day 7 post-randomization
Clot removal rate
Time frame: 7 days post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic thrombolysis with Tenecteplase in people with Intracerebral Haemorrhage and Minimally Invasive Treatment, run by Tongji Hospital at 51 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pan Chao, MD, PhD (86-027-83663337, ddjtzp@163.com; punctualpc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 3 (time frame: 180 days post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.