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

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).

Conditions

• Spontaneous Intracranial Hemorrhage
• Hypertension

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

• Beijing Municipal Health Commission

  collaborator OTHER_GOV

• Capital Medical University

  collaborator OTHER

• Suzhou First People's Hospital

  collaborator UNKNOWN

• Linyi People's Hospital

  collaborator OTHER

• Peking University Care Luzhong Hospital

  collaborator OTHER

• Wuzhou Red Cross Hospital

  collaborator OTHER

• Yantai Penglai Traditional Chinese Medicine Hospital

  collaborator UNKNOWN

• The First Affiliated Hospital of Hebei North University

  collaborator OTHER

• Jiaozuo Tumor Hospital

  collaborator UNKNOWN

• Hunan Provincial People's Hospital

  collaborator OTHER

• The People's Hospital of Liaoning Province

  collaborator OTHER

• The First People's Hospital of Qujing, Yunnan Province

  collaborator UNKNOWN

• Huizhou Third People's Hospital, Guangzhou Medical University

  collaborator OTHER

• Nanyang Nanshi Hospital, Henan University

  collaborator UNKNOWN

• Xing'anmeng People's Hospital

  collaborator UNKNOWN

• Beijing Aerospace Center Hospital

  collaborator UNKNOWN

• Xuanwu Hospital, Beijing

  lead OTHER

Principal Investigators

• Xiuhai Guo, MD, PhD · Xuanwu Hospital, Beijing

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-31

Primary Completion

2025-12-31

Completion

2026-07-01

Countries

• China

Study Locations