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Multi-center study on time window of active hypotension in acute stage of cerebral hemorrhage

Multi-center study on time window of active hypotension in acute stage of cerebral hemorrhage

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093071
Enrollment
Unknown
Registered
2024-11-28
Start date
2024-10-24
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

cerebral hemorrhage

Interventions

The time from onset to initiation of hypotension is 0-2 hours:none
The time from onset to initiation of hypotension is 2-4 hours:none
The time from onset to initiation of hypotension is 4-6 hours:none

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) Age >18 years old; 2) Spontaneous cerebral parenchymal hemorrhage confirmed by emergency CT that can be treated with hypotensive therapy within 6 hours of onset; 3) Baseline systolic blood pressure persistence >150mmHg; 4) Baseline GCS score >5; 5) Patients or their immediate family members can cooperate with informed consent.

Exclusion criteria

Exclusion criteria: 1) The time of onset is unknown; 2) There are definite diseases that cannot strengthen hypotension, such as severe intracranial and extracranial arterial stenosis (>75%), renal insufficiency, etc.; 3) There is secondary cerebral hemorrhage, such as hemorrhage secondary to brain structural abnormalities (AVM, moyamoya disease, aneurysm, cavernous hemangioma, brain tumor, etc.); 4) Cerebral hemorrhage caused by coagulation dysfunction, including blood system lesions and coagulation dysfunction caused by the use of anticoagulant drugs; 5) Cerebral hemorrhage after thrombolysis; 6) History of stroke within 30 days; 7) Serious medical diseases such as liver and kidney insufficiency, advanced tumors, heart failure, respiratory failure, and severe dementia; 8) Patients with contraindications to nicardipine and urapidil (severe aortic stenosis, severe mitral stenosis, obstructive hypertrophic cardiomyopathy, acute cardiac insufficiency, severe myocardial infarction, pulmonary embolism, etc.); Or allergic to nicardipine or uradil; 9) Baseline mRS Score >2; 10) Neurosurgical intervention is considered in the short term.

Design outcomes

Primary

MeasureTime frame
Functional outcome at 90 days of onset;

Secondary

MeasureTime frame
Hematoma enlargement 24 hours after onset;NIHSS score;Ordinal analysis of mRS Scores at 90 days after onset;90-day ADL of daily living;

Countries

China

Contacts

Public ContactJianhui Fu

Department of Neurology, Huashan Hospital, Fudan University

jianhuifu@126.com+86 137 0181 8645

Outcome results

None listed

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