Tranexamic Acid with Blood Pressure Lowering in Early Brain Bleeding
Tests tranexamic acid with blood pressure lowering in adults with early brain bleeding.
Plain-language title generated from the registry record
Registry title: Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06760078, who can take part
Where in China
- Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xuanwu Hospital, Beijing
- Trial code
- NCT06760078
- Record updated
- 7 January 2025
- Original description
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).Read full original descriptionShow less
Safety and Efficacy of Intravenous Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage
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).
Inclusion: 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: Scheduled for surgical intervention (i.e., hematoma evacuation, craniectomy); Antihypertensive therapy contraindications; Pre-illness mRS > 2; Primary thalamic hemorrhage or intracerebral hemorrhage that has extended into the ventricles; Traumatic brain injury-related hemorrhage; Recent stroke, TIA, or thrombolytic therapy; Active thrombosis or thromboembolic history; Epilepsy history; Allergy to TXA or antifibrinolytics; Blood disorders, platelets <50,000/µL, or INR ≥1.8; GFR <90 mL/min; Elevated ALT or liver disease; Secondary ICH from tumors, AVMs, and aneurysms; On anticoagulants; Indications for immediate blood pressure reduction; Hereditary or acquired thrombophilia; Acquired color vision deficiency; Life expectancy <12 months; Pregnant or lactating women; In other interventional clinical trials; Other investigator-defined ineligibilities.