Safety and Efficacy of Intravenous Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 532
- Locations
- 1
- Primary Endpoint
- modified Rankin Scale (mRS) of 0-3 at 90 days
Overview
Brief Summary
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).
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18 to 80 years old;
- •A definite diagnosis of supratentorial brain parenchymal hemorrhage by non-contrast cranial CT scan;
- •Hemorrhage volume less than 40 mL, as calculated using the ABC/2 method, with ultra-early hemorrhage growth (uHG) 10 mL/h or higher;
- •A clear time of symptom onset, and the randomization must occur within 2 hours from the onset;
- •At least two measurements of systolic blood pressure that are ≥150 mmHg and \<220 mmHg, with at least a 2-minute interval between measurements.;
- •Baseline NIHSS of 8 or higher, or unilateral limb muscle strength of 0-3 grades;
- •GCS score greater than 8;
- •The patient or their legal representative has signed an informed consent form.
Exclusion Criteria
- •Pre-illness mRS \> 2;
- •Primary thalamic hemorrhage or intracerebral hemorrhage that has extended into the ventricles;
- •Scheduled for surgical intervention (i.e., hematoma evacuation, craniectomy);
- •Secondary ICH from tumors, AVMs, and aneurysms;
- •Traumatic brain injury-related hemorrhage;
- •Recent stroke, TIA, or thrombolytic therapy;
- •On anticoagulants;
- •Blood disorders, platelets \<50,000/µL, or INR ≥1.8;
- •Antihypertensive therapy contraindications;
- •Indications for immediate blood pressure reduction;
Arms & Interventions
Tranexamic acid (TXA) group
Intravenous tranexamic acid 1 g over 10 minutes, followed by 1 g over 8 hours, with intensive blood pressure lowering.
Intervention: intravenous tranexamic acid (TXA) infusion (Drug)
Control group
An intravenous placebo (normal saline) over 10 minutes, followed by another continuous infusion of placebo over 8 hours, with intensive blood pressure lowering maintained.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
modified Rankin Scale (mRS) of 0-3 at 90 days
Time Frame: 90 ± 7 days
Secondary Outcomes
- Hematoma expansion at 24 hours(24±3 hours)
- Absolute intracerebral haematoma growth at 24 hours(24±3 hours)
- Relative intracerebral haematoma growth at 24 hours(24±3 hours)
- Intraventricular hematoma (IVH) growth at 24 hours(24±3 hours)
- National Institutes of Health Stroke Scale (NIHSS) score at 24 hours(24±3 hours)
- Neurologic deterioration in first 24 hours(24±3 hours)
- modified Rankin Scale (mRS) score at 90 days(90±7 days)
- Received surgical intervention within 7 days(Within 7±3 days)
- modified Rankin Scale (mRS) score of 0-4 at 90 days(90±7 days)
- Utility weighted modified Rankin Scale (mRS) score at 90 days(90±7 days)
- Severe hypotension(Within 72 hours)
- Major thromboembolic events(Within 90±7 days)
- Death due to any cause within 90 days(Within 90±7 days)