Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury

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

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?"

Study Overview

• Status: Completed
• Conditions: Brain Injuries
• Intervention / Treatment: Drug: tranexamic acid

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.

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen
    • Muang district, Khon Kaen, Thailand, 40000
      • Khon Kaen Regional hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Transamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain	24 ± 8 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Functional scale (GOS), mortality, operative treatment (later surgery for bleeding), adverse effect and transfusion need	at discharge period

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: September 16, 2008
• First Submitted That Met QC Criteria: September 16, 2008
• First Posted (Estimate): September 18, 2008

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: November 20, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Adults; Human; Traumatic brain injury (TBI); Moderately severe TBI; Delayed traumatic intracranial haemorrhage; Expanding traumatic intracranial haemorrhage; Progressive intracranial haemorrhage (PIH); Antifibrinolytic agent; Tranexamic acid (TXA); Randomised, placebo-controlled trial
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Hemorrhage; Brain Injuries, Traumatic; Intracranial Hemorrhages; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: HE 510606