Brain InjuriesPhase 3NCT00755209
Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Traumatic Brain Injury
A Phase 3 study testing tranexamic acid in people with Brain Injuries, run by Khon Kaen University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Brain Injuries
- What is being tested?
- tranexamic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2008to Oct 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Khon Kaen Regional hospital
Muang District, Changwat Khon Kaen, 40000
About this study
Official title: 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?"
Read the 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.
- Conditions
- Brain Injuries
- Being tested
- tranexamic acid
- Keywords
- 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
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tranexamic acidDrug
Also called Transamin
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain
Measured: 24 ± 8 hours
Secondary outcomes (1)
Functional scale (GOS), mortality, operative treatment (later surgery for bleeding), adverse effect and transfusion need
Measured: at discharge period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Collaborators
- Thailand Research Fund, Khon Kaen Hospital
- Responsible party
- Principal investigator, Surakrant Yutthakasemsunt, Khon Kaen University
- Investigators
- Surakrant - Yutthakasemsunt, M.D., Study chair, Faculty of Medicine; Khon Kaen University and Surgical unit; Khon Kaen Regional Hospital, ThailandWarawut - Kittiwattanagul, M.D., Principal investigator, Surgical Unit, Khon Kaen Regional Hospital, ThailandParnumas - Piyavechvirat, M.D., Principal investigator, Surgical Unit, Khon Kaen Regional Hospital, ThailandProfessor Pisake - Lumbiganon, M.D.,M.S., Principal investigator, Faculty of Medicine; Khon Kaen University, ThailandAsso. Professor Bandit - Thinkhamrop, M.P.H., Ph.D, Principal investigator, Faculty of Public Health; Khon Kaen University, ThailandProfessor Nakornchai - Phuenpathom, B.Sc., M.D., Principal investigator, Faculty of Medicine, Prince of Songkla University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755209
- Sponsor's protocol ID
- HE 510606
- Status last verified
- Nov 2013
- First submitted
- 16 Sep 2008
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid for Preventing Progressive Intracranial Haemorrhage in Adults With Traumatic Brain Injury; a Randomised, Double-blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00755209
- Acronym / sponsor ID
- HE 510606
- Conditions
- Brain Injuries
- Keywords
- 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)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Collaborators
- Thailand Research Fund, Khon Kaen Hospital
- Study start
- Oct 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transamin | Placebo comparator | Drug: tranexamic acidDrug: 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tranexamic acidAlso: TransaminLoading 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 | Transamin |
Primary outcome
Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain
Time frame: 24 ± 8 hours
1 secondary outcome
Functional scale (GOS), mortality, operative treatment (later surgery for bleeding), adverse effect and transfusion need
Time frame: at discharge period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surakrant - Yutthakasemsunt, M.D. study chair
Faculty of Medicine; Khon Kaen University and Surgical unit; Khon Kaen Regional Hospital, Thailand
Warawut - Kittiwattanagul, M.D. principal investigator
Surgical Unit, Khon Kaen Regional Hospital, Thailand
Parnumas - Piyavechvirat, M.D. principal investigator
Surgical Unit, Khon Kaen Regional Hospital, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tranexamic acid in people with Brain Injuries, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progressive intracranial haemorrhage at 24 ± 8 hours confirmed by repeated CT Brain (time frame: 24 ± 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.