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Clinical Trial NCT07208097 (STEPS) for Intracerebral Haemorrhage, Minimally Invasive Treatment is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage (STEPS) 768 Randomized Multi-Center Open-Label

Recruiting
Clinical Trial NCT07208097 (STEPS) is an interventional study for Intracerebral Haemorrhage, Minimally Invasive Treatment that is recruiting. It started on October 25, 2025 with plans to enroll 768 participants. Led by Tongji Hospital, it is expected to complete by June 30, 2028. The latest data from ClinicalTrials.gov was last updated on December 1, 2025.
Brief Summary
This is an 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 for intracerebral hemorrhage combined with TNK liquefaction drainage, single TNK dose of...Show More
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 in...

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Official Title

Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage

Conditions
Intracerebral HaemorrhageMinimally Invasive Treatment
Other Study IDs
  • STEPS
  • TJ-IRB202511008
NCT ID Number
NCT07208097
Start Date (Actual)
2025-10-25
Last Update Posted
2025-12-01
Completion Date (Estimated)
2028-06-30
Enrollment (Estimated)
768
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
intracerebral haemorrhage
minimally invasive treatment
hematoma evacuation
tenecteplase
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalMIS+TNK
In this group, patients receive standard medical treatment plus stereotactic minimally invasive aspiration combined with tenecteplase. The single dose of tenecteplase is 0.5mg.
Stereotactic thrombolysis with Tenecteplase
Stereotactic thrombolysis with Tenecteplase for ICH is a minimally invasive method for evacuation hematoma. The hematoma puncture target is identified via CT imaging before surgery. After local anesthesia and sedation, stereotactic minimally invasive surgery is performed with the Leksell stereotactic frame. A postoperative CT scan is immediately conducted to confirm the absence of intracranial rebleeding before admin...Show More
No InterventionStandard medical treatment
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.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Functional Improvement (good functional outcome: mRS 0-3)
The primary outcome is the proportion of patients with a favorable functional outcome (mRS score 0-3) at 180 days post-randomization.
180 days post-randomization
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Functional Improvement (Ordinal analysis of mRS)
Ordinal analysis of mRS scores at 180 days post-randomization
180 days post-randomization
Functional Improvement (uw-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)
180 days post-randomization
Functional Improvement (good functional outcome mRS 0-2)
Proportion of subjects with mRS score 0-2 at 180 days post-randomization
180 days post-randomization
Functional Improvement (good functional outcome mRS 0-1)
Proportion of subjects with mRS score 0-1 at 180 days post-randomization
180 days post-randomization
Functional Improvement (good functional outcome: eGOS 4-8)
eGOS score at 180 days post-randomization (favorable: 4-8; unfavorable: 1-3)
180 days post-randomization
Mortality
All-cause mortality at 180 days post-randomization
180 days post-randomization
Health-related quality of daily life
EQ-5D-5L score at 180 days post-randomization
180 days post-randomization
Early neurological improvement
Change in NIHSS score from baseline to Day 7 (or at early discharge if earlier)
Day 7 (or at early discharge if earlier)
Residual hematoma volume
Residual hematoma volume on Day 7 post-randomization
Day 7 post-randomization
Clot removal rate
Hematoma clearance rate at 7 days post-randomization
7 days post-randomization
Length of hospital stay and economic
ICU length of stay (from symptom onset to end of follow-up)
from symptom onset to 180 days post-randomization
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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.
Tongji Hospital logoTongji Hospital
Study Responsible Party
Tang Zhouping, Principal Investigator, Professor, Tongji Hospital
Study Central Contact
Contact: Pan Chao, MD, PhD, 86-027-83663337, [email protected]; [email protected]
2 Study Locations in 1 Countries

Anhui

Suzhou First People's Hospital, Suzhou, Anhui, 234000, China
Bin Liu, Contact, +8615255701930, [email protected]
Recruiting

Guizhou

Guizhou Medical University Affiliated Hospital, Guiyang, Guizhou, 550000, China
Active, not recruiting