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Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury

NCT00755209 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2013-11-25

No results posted yet for this study

Summary

The study's objective is to evaluate the effectiveness and safety of tranexamic acid for adult patients with moderate to severe TBI.With the research question as "Does TXA reduce the incidence of progressive intracranial haemorrhage by 50% compared to placebo in moderate to severe adult TBI patients at Khon Kaen Hospital?"

Conditions

  • Brain Injuries

Interventions

DRUG

tranexamic acid

Loading 1 gram (\~20 mg/kg) 100cc solution infuses in 30 minutes Maintenance 1 gram (\~2.5 mg/kg/hr) 1000cc solution infuses in 8 hours

Sponsors & Collaborators

  • Thailand Research Fund

    collaborator OTHER

  • Khon Kaen Hospital

    collaborator OTHER_GOV

  • Khon Kaen University

    lead OTHER

Principal Investigators

  • Surakrant - Yutthakasemsunt, M.D. · Faculty of Medicine; Khon Kaen University and Surgical unit; Khon Kaen Regional Hospital, Thailand

  • Warawut - Kittiwattanagul, M.D. · Surgical Unit, Khon Kaen Regional Hospital, Thailand

  • Parnumas - Piyavechvirat, M.D. · Surgical Unit, Khon Kaen Regional Hospital, Thailand

  • Professor Pisake - Lumbiganon, M.D.,M.S. · Faculty of Medicine; Khon Kaen University, Thailand

  • Asso. Professor Bandit - Thinkhamrop, M.P.H., Ph.D · Faculty of Public Health; Khon Kaen University, Thailand

  • Professor Nakornchai - Phuenpathom, B.Sc., M.D. · Faculty of Medicine, Prince of Songkla University, Thailand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • Thailand

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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 NCT00755209 on ClinicalTrials.gov