This is a prospective, multicenter, randomized, quadruple-blind, placebo-controlled study. This study aims to estimate the safety and efficacy of intravenous tranexamic acid (TXA) combined with intensive blood pressure lowering in ultra-early spontaneous intracerebral hemorrhage (ICH).
This trial is designed to evaluate whether tranexamic acid can reduce hematoma expansion and improve functional outcomes when combined with intensive blood pressure lowering in cases of ultra-early intracerebral hemorrhage with a high risk of hematoma expansion. Participants who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to either the TXA therapy group or the placebo control group. The initial infusion of 1 g of TXA or a matching placebo, along with intensive blood pressure lowering treatment, should commence as quickly as possible, ideally within 30 minutes of randomization. Following this, an additional 1 gram of TXA or a corresponding placebo will be administered via continuous intravenous infusion over 8 hours. Both groups will receive intensive blood pressure management during the first 24 hours after the onset of symptoms. Participants will be followed for 90 days after randomization for efficacy and safety outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
532
Intravenous tranexamic acid will be administered as an initial dose of 1 g (10mL: 1g, diluted in 90 mL normal saline) over 10 minutes, followed by a maintenance dose of 1 g over 8 hours (10mL: 1g, diluted in 240 mL normal saline). Intensive blood pressure lowering will be maintained throughout the treatment period until 24 hours after onset.
An intravenous placebo (10mL NS, diluted in 90mL NS) matching the specification and appearance of TXA will be administered as an initial bolus over 10 minutes, followed by a continuous infusion of placebo (10mL NS, diluted in 240mL NS) over 8 hours, with intensive blood pressure lowering maintained throughout the treatment period and continued until 24 hours after symptoms onset.
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
modified Rankin Scale (mRS) of 0-3 at 90 days
Time frame: 90 ± 7 days
Hematoma expansion at 24 hours
The expansion is defined as a 33% or 6 mL increase from baseline hematoma volume or develop an intraventricular hemorrhage.
Time frame: 24±3 hours
Absolute intracerebral haematoma growth at 24 hours
Time frame: 24±3 hours
Relative intracerebral haematoma growth at 24 hours
Time frame: 24±3 hours
Intraventricular hematoma (IVH) growth at 24 hours
Time frame: 24±3 hours
National Institutes of Health Stroke Scale (NIHSS) score at 24 hours
Time frame: 24±3 hours
Neurologic deterioration in first 24 hours
Neurologic deterioration is defined as an increase of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) from baseline to 24 hours, or a decline of 2 or more points on the Glasgow Coma Scale (GCS).
Time frame: 24±3 hours
Received surgical intervention within 7 days
Interventions include hematoma evacuation, external ventricular drainage, and craniectomy.
Time frame: Within 7±3 days
modified Rankin Scale (mRS) score at 90 days
Time frame: 90±7 days
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modified Rankin Scale (mRS) score of 0-4 at 90 days
Time frame: 90±7 days
Utility weighted modified Rankin Scale (mRS) score at 90 days
Time frame: 90±7 days
Major thromboembolic events
This includes ischemic stroke, myocardial infarction, and pulmonary embolism.
Time frame: Within 90±7 days
Death due to any cause within 90 days
Time frame: Within 90±7 days
Severe hypotension
Hypotension with clinical consequences (including acute renal failure) that required corrective therapy with intravenous fluids, vasopressors, or hemodialysis.
Time frame: Within 72 hours