Procedures
death, intracerebral hematoma, seizures, prestroke, hematoma
ADVERSE EVENTS, THROMBOEMBOLIC EVENT, HEMATOMA, INTRACEREBRAL HEMATOMA
All participants were administered either intravenous TXA as an initial 1-g loading dose in 100-mL normal saline infused over 10 minutes and followed by another 1 g in 250-mL normal saline infused over 8 hours or placebo with an identical administration regimen. Participants received study treatment in addition to standard medical care, which included blood pressure management and use of other hemostatic agents at the discretion of the treating physicians according to local standards.All clinical assessments for the trial were performed by local investigators. At randomization, investigators recorded the participants’ age, sex, and medical history (including information on NOAC treatment), as well as vital signs, NIHSS, GCS, and prestroke mRS. In-hospital follow-up was conducted at day 2, day 7, and on the day of death or hospital discharge, whichever occurred first, to collect information on adherence to study protocol (including whether all study treatment was administered and at which date and time) and the clinical course and management (including GCS, NIHSS, blood pressure management, neurosurgical interventions, medical treatments, care setting, and adverse events). All participants were followed-up with a final outpatient visit at 90±14 days to collect information on functional status using the mRS score, care setting, predefined adverse events (major thromboembolic events, seizures, and death), and medical treatments. When participants were unable to attend an in-person 90-day interview, a structured telephone interview with them, their next of kin, or caregivers was performed instead. All participants’ data were entered by local investigators into a secure, Web-based electronic case report form, maintained by the Clinical Trial Unit Basel. Independent on-site data monitoring was performed by the Clinical Trial Unit Basel according to a predetermined monitoring plan.Baseline brain imaging was done by computed tomography (CT) as part of routine care before randomization. A follow-up CT scan was done after 24±3 hours to assess HE. All imaging assessments of deidentified scans were performed by an independent central reader (G.M.K.), masked to treatment allocation and clinical outcomes of the participants, and entered into the electronic case report. Imaging assessment included characterization of the intracerebral hematoma on baseline and follow-up nonenhanced thin-sliced (1 to 1.5 mm) CT scans (hematoma volume, location, intraventricular extension) and assessment of spot sign