Neuroendoscopic surgery for treating brain hemorrhage

Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage: a Randomised, Controlled, Open-label, Blinded Endpoint Trial

This study is testing if a new minimally invasive surgery for brain bleeding can help patients recover better than the usual treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 560 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Southwest Hospital, China (other)
• Locations: 4 sites (Chongqing, Chongqing Municipality and 3 other locations)
• Trial ID: NCT05539859 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the efficacy and safety of neuroendoscopic surgery for removing hematomas in patients with spontaneous intracerebral hemorrhage against standard conservative treatment. It is a prospective, multicenter, randomized controlled trial that will evaluate outcomes at 180 days post-treatment. The study focuses on patients with deep supratentorial cerebral hemorrhage and aims to provide evidence-based insights into the benefits of minimally invasive endoscopic techniques. The goal is to determine if this approach can improve functional outcomes without increasing the risk of complications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with specific types of deep intracerebral hemorrhage and stable hematoma conditions.

Not a fit: Patients with unstable hematomas or those with severe pre-existing neurological deficits may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to better recovery outcomes for patients suffering from intracerebral hemorrhage.

How similar studies have performed: While neuroendoscopic techniques are increasingly used, this study aims to provide robust clinical evidence, as similar multicenter trials have been limited.

Eligibility criteria

Inclusion Criteria:

1. Age 18-80 years, either sex.
2. Time from onset to the first diagnostic CT within 24 hours (for those without bystanders and with unknown onset time, use the last known time the patient was in good condition)
3. Deep (external capsule, putamen, internal capsule, caudate nucleus) supratentorial cerebral hemorrhage with a hematoma volume ≥ 25 ml.
4. Stability of the hematoma determined by two CT scans at different times after onset. If the hematoma enlarges 5ml then the stability of the hematoma can be detected by CT again after 6 hours until the randomization time window is closed.
5. Pre-randomization GCS score of 5-14 and/or NIHSS score of ≥6.
6. Pre-onset Modified Rankin Scale (mRS) score 0 or 1.
7. Blood pressure recorded 6 hours prior to randomization consistently controlled at 180 mmHg or less.
8. Randomization completed within 24 hours after the first diagnostic CT, and surgical intervention should be performed as soon as possible, no later than 6 hours after randomization, that is to say, surgery should be performed no later than 54 hours after onset.
9. Informed and voluntarily signed informed consent by the patient or family.

Exclusion Criteria:

1. Hemorrhage clinically diagnosed as a result of cerebral aneurysm, cerebrovascular malformation, moyamoya disease, traumatic brain injury, brain tumor, hemorrhagic transformation of a large cerebral infarct, coagulation dysfunction.
2. Lobar hemorrhages, thalamic hemorrhages, primary ventricular hemorrhages, cerebellum hemorrhages and brain stem hemorrhages.
3. Hematoma involving the midbrain, with dilated or unresponsive pupils.
4. Hematoma producing life-threatening occupying effects (e.g., CT showing midline deviation of more than 1 cm, loss of cisterna ambiens) or patients who are extremely unstable and unfit for enrollment.
5. Platelet count \<100×10\^9/L, international normalized ratio (INR) \>1.4.
6. Hematoma extension to ventricle and completely blocked the third or fourth ventricle.
7. Recent history of cerebral hemorrhage (less than 1 year).
8. Severe hepatic impairment with ALT 3 times the upper limit of normal, or AST 3 times the upper limit of normal. Severe renal insufficiency with glomerular filtration rate less than 30 ml/min/1.73 m2.
9. Blood pressure not effectively controlled to less than 180 mmHg despite aggressive antihypertensive therapy prior to randomization.
10. Patients with severe advanced cognitive impairment (e.g. AD) or psychiatric disorders who are unable to complete the follow-up program as required.
11. Comorbid other serious diseases such as respiratory, circulatory, digestive, urological, endocrine, immune and hematologic disorders.
12. Pregnant or lactating women, or those who expect to become pregnant within one year.

Where this trial is running

Chongqing, Chongqing Municipality and 3 other locations

• chongqing Emergency Medical Center — Chongqing, Chongqing Municipality, China (RECRUITING)
• Xiang Yang NO.1 Peoples Hospital — Hubei, Hubei, China (RECRUITING)
• Dazhu County People's Hospital — Sichuan, Sichuan, China (RECRUITING)
• Ganzhou city people's Hospita — Ganzhou, China (RECRUITING)

Study contacts

• Study coordinator: Rong Hu, MD

Conditions: Intracerebral Hemorrhage Basal Ganglia, Intracerebral hemorrhage, NeuroEndoscopic Surgery