Skip to content

Effect of ICP guided treatment on prognosis of patients with spontaneous intracerebral hemorrhage: a multicenter prospective randomized controlled study

Effect of ICP guided treatment on prognosis of patients with spontaneous intracerebral hemorrhage: a multicenter prospective randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036670
Enrollment
Unknown
Registered
2020-08-24
Start date
2021-02-01
Completion date
Unknown
Last updated
2020-12-14

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

Conditions

spontaneous intracerebral hemorrhage

Interventions

experimental group:ICP monitoring treatment
control group:Conventional treatment

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years but <= 70 years; 2. Supratentorial spontaneous intracerebral hemorrhage with or without IVH confirmed by head CT; 3. Admission within 12 hours of onset, GCS score of 5-12 on admission or GCS score decreased to < 12 within 24 hours of admission; 4. INR < 1.4; 5. No contraindications for ICP monitoring and the randomized grouping could be completed within 6 hours after admission or within 6 hours after the score dropped to the inclusion criteria.

Exclusion criteria

Exclusion criteria: 1. Patients with spontaneous cerebellar or brainstem hemorrhage or only intraventricular hemorrhage; 2. Patients with GCS score of 3-4 or bilateral pupil fixation; 3. Evidence that spontaneous intracerebral hemorrhage is caused by secondary causes, such as arteriovenous malformation, intracranial aneurysm, cerebral infarction, tumor or trauma, etc.; 4. Patients with previous brain diseases with neurological deficits or disturbance of consciousness; 5. Patients with life expectancy less than 3 days after onset of disease; 6. Pregnancy, childbirth or lactation within 30 days; 7. Taking new anticoagulants (e.g. dabigatran) within 48 hours; 8. Platelet < 50000 / mm3; 9. Patients whose family members did not agree to be included in the group.

Design outcomes

Primary

MeasureTime frame
GOSE at 90 days;

Secondary

MeasureTime frame
mRS at 90 days;

Countries

China

Contacts

Public ContactHu Jin

Huashan Hospital, Fudan University

hujindn@126.com+86 13003116904

Outcome results

None listed

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