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STOP-MSU: Stopping Haemorrhage With Tranexamic Acid for Hyperacute Onset Presentation Including Mobile Stroke Units

NCT03385928 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2023-09-28

No results posted yet for this study

Summary

The study is a prospective phase II randomised, double-blind, placebo-controlled investigator-driven trial in acute intracerebral haemorrhage patients. The study has 2 arms with 1:1 randomisation to either intravenous tranexamic acid or placebo and will test the hypothesis that in patients with spontaneous ICH, treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared to placebo.

Conditions

  • Intracerebral Haemorrhage

Interventions

DRUG

Tranexamic Acid

Investigational product given within 2 hours of symptom onset

DRUG

Normal saline

Placebo given within 2 hours of symptom onset

Sponsors & Collaborators

  • The Florey Institute of Neuroscience and Mental Health

    collaborator OTHER

  • Neuroscience Trials Australia

    lead OTHER

Principal Investigators

  • Geoffrey Donnan, MD · The Florey Institute of Neuroscience and Mental Health

  • Stephen Davis, MD · Melbourne Health Dept of Neurology & The University of Melbourne Dept of Medicine

  • Henry Zhao, MD · Melbourne Health Dept of Neurology & The University of Melbourne Dept of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-19
Primary Completion
2023-05-28
Completion
2023-05-28

Countries

  • Australia
  • Finland
  • New Zealand
  • Taiwan
  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03385928 on ClinicalTrials.gov