NCT00755209

Brief 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?"

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

September 16, 2008

Last Update Submit

November 20, 2013

Conditions

Brain Injuries

Keywords

Traumatic brain injury (TBI)AdultsModerately severe TBIDelayed traumatic intracranial haemorrhageExpanding traumatic intracranial haemorrhageProgressive intracranial haemorrhage (PIH)Antifibrinolytic agentTranexamic acid (TXA)Randomised, placebo-controlled trialHuman

Outcome Measures

Primary Outcomes (1)

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

    24 ± 8 hours

Secondary Outcomes (1)

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

    at discharge period

Study Arms (1)

Transamin

PLACEBO COMPARATOR

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

Interventions

tranexamic acidDRUG

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

Also known as: Transamin
Transamin

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khon Kaen Regional hospital

Muang District, Changwat Khon Kaen, 40000, Thailand

Location

MeSH Terms

Conditions

Brain InjuriesBrain Injuries, Traumatic

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Surakrant - Yutthakasemsunt, M.D.

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

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 16, 2008

First Posted

September 18, 2008

Study Start

October 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

TH(1)