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Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage
Sponsor: Xuanwu Hospital, Beijing
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).
Official title: Safety and Efficacy of Intravenous Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
532
Start Date
2024-12-31
Completion Date
2026-07-01
Last Updated
2025-01-07
Healthy Volunteers
No
Interventions
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.
Locations (2)
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China