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OpenTrials
Completed

NCT Number: NCT00755209

Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury

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?"

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Khon Kaen Regional hospital

Muang District, Changwat Khon Kaen, 40000, Thailand

About this study

Traumatic brain injury (TBI) is a major public health problem with poor outcome especially with progressive intracranial haemorrhage (PIH) in severe patients. There are links between coagulopathic change after brain injury and delayed traumatic haemorrhage revealed by CT brain. Antifibrinolytic treatment can reduce blood loss after surgery and perhaps in moderate to severe TBI by similar haemostatic responses. It is justified to determine benefit for reversing hyperfibrinolysis after TBI. Tranexamic acid (TXA) has been shown to have significant clinical benefit in effectively reducing surgical bleeding in systematic reviews. It has been shown to have no effect on coagulation parameters and no demonstrated harmful effect in systematic reviews. This study is designed to determine the effectiveness of TXA in preventing PIH in patients with moderate to severe TBI. The treatment regimen if effective can be applied in general trauma practice worldwide.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • moderate to severe injuries(post-resuscitation scores GCS 4-12)
  • age >= 16 year
  • non-penetrating TBI in 8 hours onset
  • first CT brain in 8 hours onset
  • non neurosurgical OR in 8 hours onset

Exclusion criteria

  • patients with coagulopathy
  • serum creatinine over than 2 mg%
  • with associated major organ injury requiring surgery within 8 hours of injury
  • pregnancy
  • receiving any medication which affects haemostasis

Treatment and study plan

Tranexamic Acid

Drug

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

Other names: Transamin

Primary outcomes

  1. Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain

    Time frame: 24 ± 8 hours

Secondary outcomes

  1. Functional scale (GOS), mortality, operative treatment (later surgery for bleeding), adverse effect and transfusion need

    Time frame: at discharge period

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Collaborators

  • Khon Kaen Hospital
  • Thailand Research Fund

Registry information

Official study title

Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Adults With Traumatic Brain Injury; a Randomised, Double-blinded, Placebo-controlled Trial

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 18, 2008
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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