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Clinical Trials in China / NCT06760078
Starting soon Phase 4

Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage

NCT06760078 · tracked via the Priya Life Science China tracker
Sponsor
Xuanwu Hospital, Beijing
Phase
Phase 4
Started
2024-12-31
Last updated
2025-01-07

Condition(s) studied

Spontaneous Intracranial HemorrhageHypertension

Investigational drug(s) / intervention(s)

intravenous tranexamic acid (TXA) infusionPlacebo

intravenous tranexamic acid (TXA) infusion: 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.

Placebo: 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.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age between 18 to 80 years old; 2. A definite diagnosis of supratentorial brain parenchymal hemorrhage by non-contrast cranial CT scan; 3. Hemorrhage volume less than 40 mL, as calculated using the ABC/2 method, with ultra-early hemorrhage growth (uHG) 10 mL/h or higher; 4. A clear time of symptom onset, and the randomization must occur within 2 hours from the onset; 5. At least two measurements of systolic blood pressure that are ≥150 mmHg and \<220 mmHg, with at least a 2-minute interval between measurements.; 6. Baseline NIHSS of 8 or higher, or unilateral limb muscle strength of 0-3 grades; 7. GCS score greater than 8; 8. The patient or their legal representative has signed an informed consent form. Exclusion Criteria: 1. Pre-illness mRS \> 2; 2. Primary thalamic hemorrhage or intracerebral hemorrhage that has extended into the ventricles; 3. Scheduled for surgical intervention (i.e., hematoma evacuation, craniectomy); 4. Secondary ICH from tumors, AVMs, and aneurysms; 5. Traumatic brain injury-related hemorrhage; 6. Recent stroke, TIA, or thrombolytic therapy; 7. On anticoagulants; 8. Blood disorders, platelets \<50,000/µL, or INR ≥1.8; 9. Antihypertensive therapy contraindications; 10. Indications for immediate blood pressure reduction; 11. Active thrombosis or thromboembolic history; 12. Hereditary or acquired thrombophilia; 13. Acquired color vision deficiency; 14. Epilepsy history; 15. GFR \<90 mL/min; 16. Elevated ALT or liver disease; 17. Allergy to TXA or antifibrinolytics; 18. Life expectancy \<12 months; 19. Pregnant or lactating women; 20. In other interventional clinical trials; 21. Other investigator-defined ineligibilities.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Xuanwu Hospital, Capital Medical University Beijing Beijing Municipality
Xuanwu Hospital, Capital Medical University Beijing Beijing Municipality

More Xuanwu Hospital, Beijing trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06760078 on ClinicalTrials.gov ↗ ← All trials in China