NCT06894433 Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage
| NCT ID | NCT06894433 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Southwest Hospital, China |
| Condition | Intracerebral Haemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 280 participants in total. It began in 2025-06-01 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multicenter, randomized, controlled clinical trial comparing neuroendoscopic hematoma removal to craniotomy in the treatment of large intracerebral hemorrhage.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-80 years old, male or female; 2. The time between onset and admission to the first diagnostic CT is within 24 hours (for no bystanders and the time of onset is unknown, the time of the last known patient in good condition is used); 3. Patients with supratentorial intracerebral hemorrhage (supratentorial intracerebral hemorrhage (supratentorial intracerebral hemorrhage) whose hematoma volume is ≥50ml or whose hematoma produces obvious space occupying effect and requires emergency surgery (including patients with cerebral hernia signs such as retarding or dilatation of light reflex of one pupil); 4. Before randomization, GCS score was 5-14, NIHSS score was ≥6; 5. mRS Before onset: 0-1 score; 6. Randomization within 24 hours after the first diagnostic CT; 7. The patient or family members are informed and voluntarily sign the informed consent; Exclusion Criteria: 1. The clinical diagnosis is caused by cerebral aneurysm, cerebrovascular malformation, moyamoya disease, brain trauma, brain tumor, massive cerebral infarction hemorrhage transformation, coagulation dysfunction, etc.; 2. Thalamic hemorrhage, primary ventricular hemorrhage; 3. Platelet count \<100×109/L, INR \> 1.4; 4. Patients with advanced cerebral hernia (such as dilated bifidus and no light reflex) or unstable vital signs cannot tolerate surgery; 5. Irreversible brain stem impairment (eye fixation, bilateral pupil dilation), GCS≤4 points; 6. Any history of parenchyma or other intracranial subarachnoid, subdural or epidural blood and surgical history in the past 30 days; 7. Patients with severe advanced cognitive impairment (such as AD) or who are not expected to complete the follow-up plan as required; 8. Complicated with other serious diseases: including respiratory, circulation, digestion, urinary, endocrine, immune and blood systems; 9. Pregnant or breastfeeding women, or those who expect to become pregnant within one year; 10. are participating in other clinical trials (excluding: observational studies that do not involve intervention, natural history and/or epidemiological studies).
Contact & Investigator
Rong Hu, MD
STUDY CHAIR
PLA Army Medical University
Frequently Asked Questions
Who can join the NCT06894433 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Intracerebral Haemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06894433 currently recruiting?
Yes, NCT06894433 is actively recruiting participants. Contact the research team at huchrong@aliyun.com for enrollment information.
Where is the NCT06894433 trial being conducted?
This trial is being conducted at Chongqing, China, Dazhou, China.
Who is sponsoring the NCT06894433 clinical trial?
NCT06894433 is sponsored by Southwest Hospital, China. The principal investigator is Rong Hu, MD at PLA Army Medical University. The trial plans to enroll 280 participants.