Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage

NCT07208097 | Recruiting DMC

• 1 other identifier: TJ-IRB202511008
• Study Type: interventional
• Target: 768
• Locations: 1 country
• Sites: 2

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 0.5mg per time or the standard medical treatment group.

Conditions

Intracerebral Haemorrhage; Minimally Invasive Treatment

Keywords

intracerebral haemorrhage; minimally invasive treatment; hematoma evacuation; tenecteplase

Outcome Measures

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.

  180 days post-randomization

Secondary Outcomes (11)

• Functional Improvement (Ordinal analysis of mRS)

  180 days post-randomization

• Functional Improvement (uw-mRS)

  180 days post-randomization

• Functional Improvement (good functional outcome mRS 0-2)

  180 days post-randomization

• Functional Improvement (good functional outcome mRS 0-1)

  180 days post-randomization

• Functional Improvement (good functional outcome: eGOS 4-8)

  180 days post-randomization

Other Outcomes (5)

• Safety outcome: All-cause mortality within 30 days post-randomization

  30 days post-randomization

• Safety outcome: Symptomatic rebleeding rate within 30 days post-randomization

  30 days post-randomization

• Safety outcome: Bacterial intracranial infection

  30 days post-randomization

Study Arms (2)

MIS+TNK

EXPERIMENTAL

In this group, patients receive standard medical treatment plus stereotactic minimally invasive aspiration combined with tenecteplase. The single dose of tenecteplase is 0.5mg.

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.

Interventions

Stereotactic thrombolysis with Tenecteplase PROCEDURE

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 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.

MIS+TNK

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (2)

Suzhou First People's Hospital

Suzhou, Anhui, 234000, China

RECRUITING

Guizhou Medical University Affiliated Hospital

Guiyang, Guizhou, 550000, China

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Pan Chao, MD, PhD

CONTACT

86-027-83663337; ddjtzp@163.com; punctualpc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: October 6, 2025
• Study Start: October 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (2)