Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury

This study has been completed.
Sponsor:
Collaborators:
Thailand Research Fund
Khon Kaen Hospital
Information provided by (Responsible Party):
Surakrant Yutthakasemsunt, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00755209
First received: September 16, 2008
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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?"


Condition Intervention Phase
Brain Injuries
Drug: tranexamic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Adults With Traumatic Brain Injury; a Randomised, Double-blinded, Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain [ Time Frame: 24 ± 8 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Functional scale (GOS), mortality, operative treatment (later surgery for bleeding), adverse effect and transfusion need [ Time Frame: at discharge period ] [ Designated as safety issue: Yes ]

Enrollment: 238
Study Start Date: October 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Transamin

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

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
Other Name: Transamin

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755209

Locations
Thailand
Khon Kaen Regional hospital
Muang district, Khon Kaen, Thailand, 40000
Sponsors and Collaborators
Khon Kaen University
Thailand Research Fund
Khon Kaen Hospital
Investigators
Study Chair: Surakrant - Yutthakasemsunt, M.D. Faculty of Medicine; Khon Kaen University and Surgical unit; Khon Kaen Regional Hospital, Thailand
Principal Investigator: Warawut - Kittiwattanagul, M.D. Surgical Unit, Khon Kaen Regional Hospital, Thailand
Principal Investigator: Parnumas - Piyavechvirat, M.D. Surgical Unit, Khon Kaen Regional Hospital, Thailand
Principal Investigator: Professor Pisake - Lumbiganon, M.D.,M.S. Faculty of Medicine; Khon Kaen University, Thailand
Principal Investigator: Asso. Professor Bandit - Thinkhamrop, M.P.H., Ph.D Faculty of Public Health; Khon Kaen University, Thailand
Principal Investigator: Professor Nakornchai - Phuenpathom, B.Sc., M.D. Faculty of Medicine, Prince of Songkla University, Thailand
  More Information

No publications provided

Responsible Party: Surakrant Yutthakasemsunt, Dr., Khon Kaen University
ClinicalTrials.gov Identifier: NCT00755209     History of Changes
Other Study ID Numbers: HE 510606
Study First Received: September 16, 2008
Last Updated: November 20, 2013
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
Traumatic brain injury (TBI)
Adults
Moderately severe TBI
Delayed traumatic intracranial haemorrhage
Expanding traumatic intracranial haemorrhage
Progressive intracranial haemorrhage (PIH)
Antifibrinolytic agent
Tranexamic acid (TXA)
Randomised, placebo-controlled trial
Human

Additional relevant MeSH terms:
Brain Injuries
Hemorrhage
Intracranial Hemorrhages
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014