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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00755209

Enrollment

238

Registered

2008-09-18

Start date

2008-10-31

Completion date

2009-10-31

Last updated

2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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), Randomised, placebo-controlled trial, Human

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?

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.

Interventions

DRUGtranexamic 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026