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Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury

NCT ID: NCT00755209

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-10-31

Brief Summary

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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?"

Detailed Description

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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.

Conditions

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Brain Injuries

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type PLACEBO_COMPARATOR

tranexamic acid

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Transamin

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thailand Research Fund

OTHER

Sponsor Role collaborator

Khon Kaen Hospital

OTHER_GOV

Sponsor Role collaborator

Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Surakrant Yutthakasemsunt

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Surakrant - Yutthakasemsunt, M.D.

Role: STUDY_CHAIR

Faculty of Medicine; Khon Kaen University and Surgical unit; Khon Kaen Regional Hospital, Thailand

Warawut - Kittiwattanagul, M.D.

Role: PRINCIPAL_INVESTIGATOR

Surgical Unit, Khon Kaen Regional Hospital, Thailand

Parnumas - Piyavechvirat, M.D.

Role: PRINCIPAL_INVESTIGATOR

Surgical Unit, Khon Kaen Regional Hospital, Thailand

Professor Pisake - Lumbiganon, M.D.,M.S.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine; Khon Kaen University, Thailand

Asso. Professor Bandit - Thinkhamrop, M.P.H., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Faculty of Public Health; Khon Kaen University, Thailand

Professor Nakornchai - Phuenpathom, B.Sc., M.D.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Prince of Songkla University, Thailand

Locations

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Khon Kaen Regional hospital

Muang District, Changwat Khon Kaen, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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HE 510606

Identifier Type: -

Identifier Source: org_study_id