Intracerebral Hemorrhage
Conditions
Interventions
Standard treatment group:Intravenous normal saline
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients presenting with spontaneous intracranial hemorrhage; 2.Age betweeen 18 and 75 years; 3.Tranexamic acid can be used within 3 hours after symptom onset; 4.The baseline hematoma volume is 5-30ml; 5.Hematoma located in basal ganglia or thalamus; 6.The speed of bleeding as meassured by uHG (baseline hematoma volume/ time to baseline CT) > 5 mL/h; Or presence of any of the following NCCT markers of hematoma expansion: blend sign, black hole sign, CT hypodensity, island sign; 7.If there is intraventricular hemorrhage, ventricular hematoma volume should be less than 1/2 of the lateral ventricle; 8.Informed consent has been obtained in accordance to local ethics committee requirement.
Exclusion criteria
Exclusion criteria: 1.Glasgow coma scale (GCS) score 2; 5.Life expectancy less than 3 months; 6.Contraindications to tranexamic acid; 7.Wake up stroke or stroke of unknown onset; 8.Pregnancy; 9.Concurrent use or planned treatment with hemostatic agents; 10.Participation in any interventional study within 30 days; 11.Inability to comply with study procedures due to mental illness; 12.Known terminal illness or planned for withdrawal of care; 13.Patients considered unsuitable for this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of hematoma expansion by 24 ± 12 hours; | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute volume of hematoma expansion by 24 ± 12 hours;Presence of newly occuring intraventricular hemorrhage or intraventricular hemorrhage growth by 24±12 hours;Shift in mRS at 3 months;Functional indepenence defined as mRS socre of 0-2 at 3 months;Mortality or major disability defined as mRS score of 4-6 at 3 months;Death due to any cause at 3 months; | — |
Countries
China
Contacts
Public ContactQi Li
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed