Last updated: November 19, 2021
Sponsor: First Affiliated Hospital of Fujian Medical University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Hemorrhage
Stroke
Brain Injury
Treatment
N/AClinical Study ID
NCT03862729
GN-2018R002
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
- Retrospective part Inclusion Criteria:
- Emergent CT showed a spontaneous supratentorial intracerebral hemorrhage (patientwith a small amount of intraventricular hemorrhage is eligible);
- Patients should have undergone baseline CT scan within 48 hours after hemorrhageonset and repeated fewer than 48 hours after the baseline CT;
- Patients without herniation.
- Patients were treated by observation before hemorrhage growth (if happened).
Exclusion
Exclusion Criteria:
- Spontaneous intracerebral hemorrhage secondary to an underlying structural causeidentified by brain imaging, (ie, vascular malformation, aneurysm, tumor);
- The time from symptom onset to baseline imaging was not known in hours, clinicalinformation or lab results was not enough to determine the growth of the hematomaor to perform statistical analysis;
- Patients had accepted acute treatment that might have reduced intracerebralhemorrhage volume (ie, surgical evacuation, external ventricular drainage, lumbarpuncture).
- Prospective part Inclusion Criteria:
- Emergent CT showed a spontaneous supratentorial intracerebral hemorrhage (patient witha small amount of intraventricular hemorrhage is eligible);
- Patients without herniation meet the clinical uncertainty principle as follows: theresponsible neurosurgeon is uncertain about the benefits of surgery.
- Patients should have undergone baseline CT scan within 24 hours after hemorrhageonset; the volume of the hematoma is more than 20 ml and less than 100ml on the firstCT scan.
- Patients with a Glasgow coma score of 5 or more.
- Informed consent, and willing to accept long-term follow-up. Exclusion Criteria:
- Spontaneous intracerebral hemorrhage secondary to an underlying structural causeidentified by brain imaging, (ie, vascular malformation, aneurysm, tumor);
- patients had a cerebellar hemorrhage or extension of a supratentorial hemorrhage intothe brainstem;
- patients had severe pre-existing physical or mental disability or severe comorbiditythat might interfere with the assessment of outcome.
- Severe coagulopathy, INR cannot be reversed to less than or equal to 1.5
- Patients during pregnancy or lactation.
Study Design
Total Participants: 1300
Study Start date:
July 01, 2019
Estimated Completion Date:
March 31, 2022
Study Description
Connect with a study center
The first affiliated hospital of fujian medical university
Fuzhou, Fujian 350005
ChinaActive - Recruiting
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