Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage

Recruiting now · Not applicable

Conditions studied: Intracerebral Hemorrhage Basal Ganglia

In brief

To compare the efficacy and safety of neuroendoscopic hematoma removal and standard conservative treatment for patients with spontaneous supratentorial deep intracerebral hemorrhage.

Key facts

Study ID

NCT05539859

Run by

Southwest Hospital, China

People needed

560

Starts

2022-11-18

Expected to finish

2026-09-01

Last updated by the study team

2024-05-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-80 years, either sex.
• 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)
• Deep (external capsule, putamen, internal capsule, caudate nucleus) supratentorial cerebral hemorrhage with a hematoma volume ≥ 25 ml.
• 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.
• Pre-randomization GCS score of 5-14 and/or NIHSS score of ≥6.
• Pre-onset Modified Rankin Scale (mRS) score 0 or 1.
• Blood pressure recorded 6 hours prior to randomization consistently controlled at 180 mmHg or less.
• 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.
• Informed and voluntarily signed informed consent by the patient or family.

You may not qualify if…

• 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.
• Lobar hemorrhages, thalamic hemorrhages, primary ventricular hemorrhages, cerebellum hemorrhages and brain stem hemorrhages.
• Hematoma involving the midbrain, with dilated or unresponsive pupils.
• 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.
• Platelet count <100×10\^9/L, international normalized ratio (INR) >1.4.
• Hematoma extension to ventricle and completely blocked the third or fourth ventricle.
• Recent history of cerebral hemorrhage (less than 1 year).
• 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.
• Blood pressure not effectively controlled to less than 180 mmHg despite aggressive antihypertensive therapy prior to randomization.
• Patients with severe advanced cognitive impairment (e.g. AD) or psychiatric disorders who are unable to complete the follow-up program as required.
• Comorbid other serious diseases such as respiratory, circulatory, digestive, urological, endocrine, immune and hematologic disorders.
• Pregnant or lactating women, or those who expect to become pregnant within one year.

Where it is running

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

Full record on ClinicalTrials.gov

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