Status:
UNKNOWN
Risk Stratification and Minimally Invasive Surgery in Acute ICH Patients
Lead Sponsor:
First Affiliated Hospital of Fujian Medical University
Collaborating Sponsors:
National Health and Family Planning Commission, P.R.China
Conditions:
Spontaneous Intracerebral Hemorrhage
Eligibility:
All Genders
18-80 years
Brief Summary
The study consists of 2 parts: the first part is to conduct a multicenter retrospective analysis of more than 1000 acute ICH patients treated by conservative observation from 33 centers in China to cr...
Detailed Description
Spontaneous intracerebral hemorrhage (ICH) accounts for 2 million strokes worldwide per year and is the deadliest subtype of stroke with a 1-year mortality rate up to 50%. Given the high morbidity and...
Eligibility Criteria
Inclusion
- Retrospective part
- Emergent CT showed a spontaneous supratentorial intracerebral hemorrhage (patient with a small amount of intraventricular hemorrhage is eligible);
- Patients should have undergone baseline CT scan within 48 hours after hemorrhage onset and repeated fewer than 48 hours after the baseline CT;
- Patients without herniation.
- Patients were treated by observation before hemorrhage growth (if happened).
Exclusion
- Spontaneous intracerebral hemorrhage secondary to an underlying structural cause identified by brain imaging, (ie, vascular malformation, aneurysm, tumor);
- The time from symptom onset to baseline imaging was not known in hours, clinical information or lab results was not enough to determine the growth of the hematoma or to perform statistical analysis;
- Patients had accepted acute treatment that might have reduced intracerebral hemorrhage volume (ie, surgical evacuation, external ventricular drainage, lumbar puncture).
- Prospective part
- Inclusion Criteria:
- Emergent CT showed a spontaneous supratentorial intracerebral hemorrhage (patient with a small amount of intraventricular hemorrhage is eligible);
- Patients without herniation meet the clinical uncertainty principle as follows: the responsible neurosurgeon is uncertain about the benefits of surgery.
- Patients should have undergone baseline CT scan within 24 hours after hemorrhage onset; the volume of the hematoma is more than 20 ml and less than 100ml on the first CT scan.
- Patients with a Glasgow coma score of 5 or more.
- Informed consent, and willing to accept long-term follow-up.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT03862729
Start Date
July 1 2019
End Date
March 31 2022
Last Update
November 22 2021
Active Locations (1)
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1
The first affiliated hospital of fujian medical university
Fuzhou, Fujian, China, 350005