Actively Recruiting
Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
Led by Tongji Hospital · Updated on 2025-12-01
768
Participants Needed
2
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 0.5mg per time or the standard medical treatment group.
CONDITIONS
Official Title
Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years, any gender.
- Acute spontaneous supratentorial intracerebral hemorrhage confirmed by CT within 24 hours of symptom onset.
- Hematoma volume between 25 mL and 60 mL confirmed by CT using the ABC/2 method.
- National Institutes of Health Stroke Scale (NIHSS) score of 6 or higher.
- Glasgow Coma Scale (GCS) score between 9 and 14.
- Pre-stroke modified Rankin Scale (mRS) score of 1 or less.
- Ability to comply with study procedures and provide written informed consent by patient or legal guardian.
You will not qualify if you...
- Brainstem or cerebellar hemorrhage, or thalamic hemorrhage with significant midbrain shift and nerve palsy.
- Irreversible brainstem dysfunction (fixed dilated pupils, decerebrate posturing).
- Secondary intracerebral hemorrhage from trauma, vascular malformations, tumors, or coagulation disorders.
- Severe coagulation abnormalities, liver or kidney failure, low hemoglobin or platelet counts.
- History of malignancy, autoimmune diseases, severe cardiac conditions, infections, or other severe illnesses.
- High risk of thromboembolism including mechanical heart valves or certain cardiac conditions.
- Recent myocardial infarction, anticoagulant use within one week, or recent internal bleeding.
- Major surgery or vascular puncture within three months prior to randomization.
- Significant head trauma or stroke within three months prior.
- Prior intracerebral hemorrhage within one year.
- Indications for craniotomy or brain herniation signs.
- Intraventricular hemorrhage requiring drainage.
- Patient or family requests for craniotomy or neuroendoscopic surgery.
- Do-Not-Resuscitate or Do-Not-Intubate orders.
- Known allergy to Tenecteplase.
- Pregnancy in women of childbearing potential.
- Participation in another investigational study.
- History of drug or alcohol abuse, severe dementia, or psychiatric disorder impairing compliance.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Suzhou First People's Hospital
Suzhou, Anhui, China, 234000
Actively Recruiting
2
Guizhou Medical University Affiliated Hospital
Guiyang, Guizhou, China, 550000
Active, Not Recruiting
Research Team
P
Pan Chao, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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