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Analysis of the curative effect of ultra-early (< 8 hours) craniotomy on high grade intracranial aneurysm: a prospective multicenter randomized controlled trial

Analysis of the curative effect of ultra-early (< 8 hours) craniotomy on high grade intracranial aneurysm: a prospective multicenter randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030567
Enrollment
Unknown
Registered
2020-03-07
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid hemorrhage

Interventions

control group:early craniotomy(8-24 hours)
experimental group:ultra-early craniotomy (<8 hours)

Sponsors

904th Hospital of Joint Logistic Support Force of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, gender unlimited. 2. Patients with intracranial aneurysm confirmed by CTA / DSA / MRA, which is responsible for the recent subarachnoid hemorrhage. 3. Patients are in poor neurological condition (Hunt & Hess Grades IV or V) on admission. 4. Patients whose time from onset to randomization and emergency operation is less than 8 hours. 5. According to ethics committee requirements, the person responsible for the patient must agree to participate in this trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. With Pseudoaneurysm; 2. Drug addicts; 3. Patients with basic diseases that seriously affect the prognosis, long-term oral aspirin before operation, coagulation dysfunction and other diseases that affect the effect of operation; 4. With serious coagulation dysfunction; 5. With organ failure; 6. With serious psychosomatic diseases; 7. Pregnant or lactating women. 8. The persons responsible for the patient refuse to give consent to participate in this trial; 9. Patients are participating in another randomized clinical trial for treatment of SAH.

Design outcomes

Primary

MeasureTime frame
mRS at 6 months;

Secondary

MeasureTime frame
All-Cause Mortality witnin 90 days;Incidence of delayed cerebral infarction;Incidence of hydrocephalus;Incidence of cerebral vasospasm;

Countries

China

Contacts

Public ContactYuhai Wang

Neurosurgery Department of 904th Hospital of Joint Service Support Force of PLA

wangyuhai67@126.com+86 13771166231

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026