Non-traumatic intracerebral and intraventricular hemorrhage. Nontraumatic intracerebral hemorrhage
Conditions
Interventions
Intervention 1: Intervention group: Patients in the intervention group will receive 1 gram of intravenous tranexamic acid diluted in 100 milliliters of normal saline as a loading dose, followed by an
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Individuals over 18 years of age with acute, non-traumatic intracerebral hemorrhage, within a maximum of 6 hours from the onset of bleeding
Exclusion criteria
Exclusion criteria: Patients with intracerebral hemorrhage secondary to anticoagulant use, thrombolysis, or known structural abnormalities such as arteriovenous malformations (AVMs), aneurysms, or tumors Patients with contraindications to tranexamic acid (such as active intravascular clotting, a history of thromboembolic diseases, or hypersensitivity to tranexamic acid) Modified Rankin Scale (mRS) >4 Glasgow coma scale <5 Intracerebral hemorrhage secondary to trauma Subarachnoid hemorrhage (SAH) Subdural hemorrhage (SDH) Epidural hemorrhage (EDH) Pregnant or lactating women at the time of randomization Geographical or other factors that hinder follow-up at 90 days, such as lack of a permanent address or contact phone number
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional outcome measured by the Modified Rankin Scale (mRS) score at day ninety after randomization. Timepoint: Baseline before randomization and day ninety (or discharge day) after randomization. Method of measurement: Use of the modified Rankin Scale questionnaire (range 0 to 6) administered in person by a trained assessor who is blinded to group allocation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematoma expansion defined as an increase in intracerebral hemorrhage volume of at least thirty three percent or at least six milliliters between baseline and follow up imaging. Timepoint: Baseline imaging at enrollment and follow up imaging at twenty four to seventy two hours after randomization. Method of measurement: Non contrast computed tomography scans with hematoma volume measured by the ABC divided by two method or by planimetry on the hospital imaging workstation read by a radiologist who is blinded to group allocation.;All-cause mortality up to the day of discharge (or death) following randomization. Timepoint: From the time of randomization until the day of discharge (or death). Method of measurement: Review of the hospital record and follow-up telephone assessment by the blinded assessor, confirmed by official records where permitted. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAfshin Gharekhani
Tabriz University of Medical Sciences
Outcome results
None listed