Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTongji Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
. 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.
Disqualifiers
. 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.
Trial design
Design model
Parallel
Treatments tested in this trial
Stereotactic thrombolysis with Tenecteplase
Procedure/SurgeryStereotactic 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 administering tenecteplase into the hematoma. 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 can be administered with a maximum of 2 dose in every 24 hours. The target hematoma clearance criteria is: residual hematoma volume ≤10 mL or ≤20% of the initial volume.
Treatment groups
768 Participants
are divided into 2 treatment groupsGroup A: MIS+TNKExperimental treatment 1 intervention
Group B: Standard medical treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
180 days post-randomizationSecondary outcomes
1
Functional Improvement (Ordinal analysis of mRS)
Ordinal analysis of mRS scores at 180 days post-randomization
Time frame
180 days post-randomization2
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)
Time frame
180 days post-randomization3
Functional Improvement (good functional outcome mRS 0-2)
Proportion of subjects with mRS score 0-2 at 180 days post-randomization
Time frame
180 days post-randomization4
Functional Improvement (good functional outcome mRS 0-1)
Proportion of subjects with mRS score 0-1 at 180 days post-randomization
Time frame
180 days post-randomizationOther outcomes
1
Safety outcome: All-cause mortality within 30 days post-randomization
All-cause mortality within 30 days post-randomization is the primary safety outcome
Time frame
30 days post-randomization2
Safety outcome: Symptomatic rebleeding rate within 30 days post-randomization
Symptomatic rebleeding rate within 30 days post-randomization
Time frame
30 days post-randomization3
Safety outcome: Bacterial intracranial infection
Intracranial infection rate within 30 days post-randomization
Time frame
30 days post-randomization4
Serious Adverse Events
Overall incidence of Serious Adverse Events within 180 days post-randomization
Time frame
180 days post-randomizationSponsors and contacts
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Source ClinicalTrials.gov